President Donald Trump signed an Executive Order on Thursday last week directing the Attorney General to expedite completion of marijuana rescheduling begun in October 2022 to facilitate medical research.  There was uncertainty whether President Trump, now in the White House, would support rescheduling.  Candidate Trump posted in September 2024, “As President, we will continue to focus on research to unlock the medical uses of marijuana to a Schedule 3 drug, and work with Congress to pass common sense laws, including safe banking for state authorized companies, and supporting states’ rights to pass marijuana laws, like in Florida.” Donald Trump (@realDonaldTrump), Truth Social (Sept. 8, 2024 at 23:18 ET).

In August 2023, the Department of Health and Human Services (“HHS”), after conducting the required Eight Factor Analysis under the Controlled Substances Act (“CSA”), recommended that the Drug Enforcement Administration (“DEA”) reschedule marijuana from schedule I to schedule III.  HHS found that 30,000 licensed healthcare practitioners were authorized to recommend marijuana for medical use to over six million patients to treat pain, anorexia related to certain medical condition, and nausea and vomiting from chemotherapy.  The Department of Justice conducted a separate Eight Factor Analysis and concurred with HHS’ rescheduling recommendation.  Then-Attorney General Merrick Garland signed a Notice of Proposed Rulemaking (“NPRM”) in May 2024 proposing to reschedule marijuana to schedule III that elicited over 43,500 public comments.  Last January, a public hearing on whether marijuana should be rescheduled was placed on hold pending an appeal by several parties.

The Executive Order’s stated purpose is to improve and facilitate medical research with marijuana and asserts that the “[f]ederal government’s long delay in recognizing the medical use of marijuana does not serve the Americans who report health benefits from the medical use of marijuana to ease chronic pain” and other ailments.  It opines that marijuana’s classification as a schedule I substance has actually “impeded research.”  The Executive Order also seeks to facilitate non-controlled cannabidiol (“CBD”) research for medical treatment.

The Executive Order directs Attorney General Pam Bondi to “take all necessary steps to complete the rulemaking process to reschedule marijuana to Schedule III of the CSA in the most expeditious manner” consistent with the Controlled Substances Act.  But how will the Attorney General bring rescheduling to a close?  Will DEA pick-up where the rescheduling hearing left off in January or will the agency simply issue a final order?

The Executive Order also mandates the Administration to work with Congress to update the statutory definition of hemp derived-CBD products for medical use of full spectrum CBD, while preserving congressional intent to restrict the sale of products posing serious health risks.  This would include developing guidance on upper THC limits.  The Executive Order further requires the responsible federal agencies to develop research methods and models utilizing “real-world evidence” to improve access to hemp-derived CBD products and inform standards of care.

The President’s action follows passage of the Medical Marijuana and Cannabidiol Research Expansion Act (Public Law 117-215) enacted in December 2022 to facilitate research of marijuana and its derivatives, including CBD, for development of approved medications.  The law requires DEA to ensure an adequate and uninterrupted supply for research.  It mandates that DEA streamline and accelerate registration application procedures for marijuana researchers and manufacturers of marijuana for research.  And it mandates HHS to assess, and with the National Institutes of Health report, on marijuana’s potential therapeutic and health effects.

The Executive Order directs finalizing rulemaking to reschedule marijuana from the most stringently regulated class of controlled substances, which includes heroin and LSD, to schedule III, the class with Tylenol with codeine, testosterone, buprenorphine, butalbital, and pentobarbital.  Reclassification to schedule III would acknowledge that marijuana, as with other drugs in that schedule, has a currently accepted medical use in the U.S., a potential for abuse less than drugs in schedule I and II, and a potential for abuse that may lead to moderate or low physical dependence or high psychological dependence.  21 U.S.C. § 812 (b)(3).  Rescheduling marijuana to schedule III would bring federal regulatory requirements into closer alignment with the forty states that authorize it for medical purposes.  It would not authorize marijuana for adult recreational use.

The May 2024 NPRM confirmed that if marijuana were rescheduled to schedule III, “regulatory controls applicable to schedule III controlled substances would apply, as appropriate, along with existing marijuana-specific requirements and any additional controls that might be implemented, including those that might be implemented to meet U.S. treaty obligations.”  Schedules of Controlled Substances: Rescheduling of Marijuana, 89 Fed. Reg. 44,597, 44,621 (May 21, 2024).

Rescheduling to schedule III would subject marijuana cultivators, producers, processors, distributors, importers, exporters, dispensers, and practitioners to specific regulatory requirements under the CSA and DEA regulations.  Requirements would vary depending on the registered business activity.

Rescheduling to the less restrictive schedule unless exemptions are established would still require marijuana businesses to obtain DEA registrations, take initial and biennial inventories of marijuana on-hand, maintain transaction records, file theft and significant loss reports, and label and secure products.  Dispensing marijuana to patients, as required for other schedule III substances, would require a prescription issued for legitimate medical purpose by a DEA-registered and state-licensed practitioner.  21 U.S.C. § 829(b).  Pharmacists have to exercise their corresponding responsibility to ensure that marijuana they dispense is prescribed for legitimate medical purpose.  21 C.F.R. § 1306.04(a).  Marijuana activities would be subject to CSA criminal prohibitions under 21 U.S.C. §§ 841-844.  89 Fed. Reg. at 44,621.  Marijuana would also remain subject to applicable provisions of the Federal Food, Drug, and Cosmetic Act. Id.

As we have advised during different steps in the marijuana rescheduling process, “buckle up.”

On December 3, 2025, the U.S. Food and Drug Administration held its public meeting on the upcoming reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years 2028–2032, known as BsUFA IV. The meeting gave regulators, manufacturers, and other stakeholders an opportunity to outline priorities for a program that now provides approximately 61% of FDA’s funding for biosimilars review activities and has supported the approval of 81 biosimilars to date.

For stakeholders, several themes emerged that will shape how biosimilars are developed, reviewed, and approved in the United States over the coming decade.

FDA Session – Opening Remarks and Background

FDA leadership emphasized that the biosimilars program continues to be a major driver of patient access and healthcare savings. Biosimilars have generated $56 billion in savings since 2015, including almost $20 billion in 2024 alone. Biosimilars lower costs in two ways: they enter the market at lower prices, and their presence also leads brand biologics to reduce prices, lowering overall spending.

FDA summarized BsUFA background, program performance, financial background and fee structure, as well as the reauthorization process.  FDA also described several BsUFA III achievements:

• New supplement categories, timelines and performance goals
• Review procedures of use-related risk analysis and human factors protocols for biosimilar combination products
• Launch of a regulatory science pilot program focused on advancing interchangeable biosimilar development
• New meeting types and follow-up clarification opportunities

At the same time, FDA is aware of the need to address the challenges related to biosimilar development, manufacturing complexity, and the evolving landscape of biological products. As the reauthorization process for BsUFA IV kicks off, FDA welcomes the participation of patients, consumer advocacy groups, industry, healthcare professionals, and scientific experts.

Industry Perspective Session

The Biosimilars Forum commended FDA’s collaboration with industry and urged a big-picture reauthorization goal focusing on:

• Improving development and process efficiency to decrease costs of development
• Ensuring stable and adequate resources for FDA’s scientific workforce
• Evaluating whether current paradigms (e.g., suffix naming conventions) remain necessary

The Forum emphasized the importance of taking a step back and looking at what should change to make BsUFA IV more efficient; because, even though better access is needed, biosimilars remain key to competition and cost savings.

The Biosimilars Council (Association for Accessible Medicines) highlighted the program’s substantial progress – such as FDA reducing the need for comparative efficacy studies – and presented several areas for improvement:

• Shortened review timelines in light of decreasing reliance on comparative efficacy studies
• More efficient and transparent communication practices
• Greater efficiency and transparency in the inspection process
• Continue the increased reliance on analytical data to streamline development
• Enhanced approaches to device-related challenges (e.g., user interface differences and human factor studies, device bridging)
• Providing guidance for complex products such as antibody-drug-conjugates (ADCs) and bispecific monoclonal antibodies
• Exploring the use of a single global comparator
• Strengthening the reauthorization framework in a way that safeguards BsUFA-related resources and prevents disruptions

The Pharmaceutical Research and Manufacturers of America (PhRMA) emphasized the need to preserve and build on the successes of previous BsUFAs and for the biosimilars review process to continue to be consistent, predictable, transparent, as well as independent and science-based.  In their view, BsUFA IV should:

• Focus on core review functions, for example:
  • Improving review times

• • Ensuring that review process enhancements introduced in prior BsUFA cycles are utilized effectively and resources used optimally
  • Improve engagement and communication between FDA and biosimilar applicants
• Enhance the financial stability and sustainability of the program by:
  • Streamlining the program’s financial structure to match the FDA’s resource needs
  • Simplifying the user fee revenue process to improve predictability

Public Comment Session

Teva Pharmaceuticals appreciated FDA’s role in fostering a robust and competitive biosimilars market and acknowledged the progress made in BsUFA III. However, from Teva’s perspective, several review process issues warrant attention, for example:

• Supplement review times
• Information requests and deficiency response timelines
• Information requests and labeling comments late in the review process.

Teva expressed looking forward to discussing the possible changes that could address these challenges such as i) earlier identification of deficiencies and earlier inspection scheduling and ii) enhanced oversight of where BsUFA funds are dedicated.

Regarding final approval oversight, because the FDA is moving away from requiring Phase III-style confirmatory clinical trials for biosimilars, Teva recommended that the office most directly involved in reviewing biosimilar applications have final approval authority. That is, granting the Office of Therapeutic Biologics and Biosimilars (OTBB) signatory authority would simplify administrative complexity and reduce the involvement of the Office of New Drugs (OND) clinicians in the final sign off of biosimilar applications, allowing the clinicians to focus on reviewing innovative (i.e., non-biosimilar) drugs.

What Comes Next?

Formal negotiations for BsUFA IV begin in Spring 2026 and are expected to conclude by Summer 2026. FDA must:

• Obtain clearance for the recommendations from the various layers of federal government
• Conduct a final public meeting towards the end of 2026
• Submit final BsUFA IV recommendations to Congress by January 15, 2027

Notably, for the first time in the BsUFA program, FDA will conduct monthly periodic meetings with patient and consumer groups to obtain their input on BsUFA IV. These meetings will be conducted in parallel during the FDA-Industry negotiation meetings.

In addition, due to a new requirement, FDA will post public minutes of the FDA-Industry negotiation meetings within 30 days after each meeting.

For stakeholders interested in participating in the consultation process:

• The public comment docket for the Initial Public Meeting remains open until January 2, 2026.
• Patient and consumer groups can sign up by email BSUFAReauthorization@fda.hhs.gov by January 30th, 2026.

Conclusion

The December 2025 meeting demonstrated broad consensus on the need for a biosimilars program that is efficient, scientifically current, predictable, and sustainably funded. As biosimilars continue to play an increasingly significant role in the American health care system, BsUFA IV will be critical in shaping the regulatory environment that governs their development and approval.

For stakeholders, the upcoming negotiation cycle offers an opportunity to help define how FDA’s biosimilar review program evolves over the next five years.

Stay tuned for more updates!

On December 8, 2025, the Government Accountability Office (GAO) sent a report to Senators Richard Durbin and Richard Blumenthal in response to the Senators’ request for GAO to review FDA’s medical device recall process. At a high level, the findings are not surprising—FDA’s staffing is insufficient to conduct adequate oversight of medical devices recalls, and FDA’s legal authority limits what it can mandate of manufacturers who carry out voluntary recalls. GAO recommends:

HHS work with FDA: 1) to conduct workforce planning for device recalls, and 2) to assess and seek, if needed, additional authority for manufacturer-initiated recall strategies.

GAO stated that it made these recommendations to HHS, which concurred with the first, and is still considering the second.

1.  Workforce Planning

On the first point, it is notable that GAO’s report examines recalls overseen by FDA from FY2020 through FY2024—prior to the drastic agency reductions-in-force and departures that took place this year. It seems reasonable to assume that if FDA staff resources were previously constrained in their ability to conduct necessary recall activities, such constraints are almost certainly now further amplified by the action of the current administration with the significant voluntary and involuntary departures that have occurred in 2025.

The GAO report covers many different areas, from the process for conducting recalls to how FDA classifies recalls (Class I being highest risk, Class III lowest), interactions between FDA and industry during the conduct of a recall, and areas in which FDA has expressed an inability to oversee all aspects of a recall. While we do not intend to address all areas covered in the 49-page report, we will highlight a few notable takeaways.

a)  Device recalls are more voluminous and more multifaceted than drug or biologics recalls in many ways, adding to the complexity of FDA oversight.

The GAO report notes that “[i]n any given year, there are more device recalls than biologics and drug recalls combined.” This is not necessarily surprising, given how medical devices function as compared to drugs and biologics. For drugs and biologics, recalls are almost exclusively focused on safety issues associated with use of the product. For medical devices, recalls may be initiated for malfunctions even if those malfunctions have not caused harm, and even if the likelihood of harm is minimal. Furthermore, as noted in the report, medical devices undergo “rapid improvements and continuous enhancements” compared to biologics and drugs, making medical device oversight more challenging. The report notes that this results in FDA needing to process “a large volume of medical device recalls with limited time, insufficient staffing levels, and information technology database systems that require extensive manual data entry.”

b)  FDA staff acknowledge certain areas of lapsed recall oversight due to inadequate staffing.

The report calls out specific areas of recall oversight that are not currently undertaken due to staff shortages, including reviewing manufacturer Recall Status Reports and conducting in-person recall audit checks. According to the report, “Officials said they often forgo these activities because they must shift staff’s priorities to focus on the highest risk recalls (class I) and on the earlier stages of the recall process (initiation and classification).”  Consistent with this sentiment, as we have previously reported, and as is mentioned in the GAO report, CDRH recently implemented its Early Alert Communications program for potentially high-risk device recalls in an effort to inform the public in a more timely manner about potential risk associated with certain marketed devices.

c)  Termination of a recall by FDA is not a high priority and many months, if not years, can pass between a manufacturer’s request for recall termination and FDA’s issuance of a termination notice.

According to GAO, recall termination “is on the ‘back burner’ due to limited resources.” GAO’s investigation found that 74% of recalls across FY2020-2024 exceeded FDA’s policy of terminating a recall within three months of receiving a termination request from a manufacturer.

From a patient and provider perspective, these delays can sow confusion. As discussed in the report, if the recall has not been terminated, patients and providers may continue to believe that there is an ongoing problem with a particular product, or that FDA has not been satisfied with the recall activities, when the reality may simply be that FDA has not gotten around to it. This can also create problems during mergers and acquisitions, as a buyer may be concerned about a target’s open recall, even if the recall has been resolved adequately but FDA has not issued the termination notice.

d)  Communication between FDA and industry regarding execution of a recall is mutually inadequate.

Neither FDA nor industry is entirely happy with communications during the course of a recall. Interviews with industry trade groups indicate that FDA’s classification process is a “vacuum,” making it difficult for industry to ascertain the factors that FDA considers warrant a high-risk (Class I) classification. Additionally, FDA’s focus is primarily on the earlier recall discussions, leaving industry in the dark when it comes to closing out a recall.

From the FDA perspective, it cannot mandate that manufacturers take certain steps during a recall, which can lead to frustration on FDA’s part when a manufacturer fails to do what FDA is recommending. While it is true that FDA cannot mandate certain actions be taken, in our experience, in most instances the manufacturer will work with FDA to find a mutually agreeable solution to an FDA request. Additionally, FDA has the ability to issue its own press release about high-risk recalls, so while it may not be able to mandate specific activities, FDA does have leverage to influence what is or is not communicated to customers and the public.

e)  Though FDA has taken steps to improve transparency related to potential device risks, it is not clear how the agency will improve the areas that are currently lacking oversight given the reductions in force.

Despite its smaller workforce, CDRH has this year put additional focus on medical device recalls. While the Early Alert program has resulted in the public becoming aware of potential issues earlier, it is not clear the extent to which this program will ultimately affect other challenges identified in the GAO report, particularly with respect to communications toward the end of a recall. To the contrary, this pilot program emphasizes industry’s concern that FDA is far more engaged at the early stages of a recall than it is at the end.

2.  Legislative Authority

GAO also recommended that FDA assess whether it needs additional authority to require manufacturers to implement certain recall strategies.  In situations when FDA and the manufacturer disagree – e.g., about language in the customer letter, or whether to conduct a removal or whether a labeling change is adequate – GAO states that FDA “should have clear and sufficient authority” to conduct effective oversight over recalls.  FDA said it would consider this recommendation, noting that there are potentially more resources required to implement these new authorities, but acknowledging that having the ability to require manufacturers to use certain language could streamline review time for recall communications.  There is legislation proposed by the requestors of the GAO report, among others, to modernize FDA’s recall notification authority; as of the date of this blog post, the House and Senate bills are working their way through the committee review process.

*****

FDA and industry both can undoubtedly benefit from improved communications, increased transparency, and a collaborative approach across the entirety of the recall process. Given the staffing shortages at the agency, it remains to be seen whether or to what extent CDRH will be able to adopt GAO’s recommendation to conduct adequate and appropriate workforce planning for improved recall oversight.

We are proud to announce that Hyman, Phelps & McNamara, P.C. (HPM) has been named to the 2026 Best Law Firms® list, receiving top-tier recognition for our work in FDA Law. The firm earned:

• National Tier 1 – FDA Law
• Regional Tier 1, Washington, D.C. – FDA Law

This honor places HPM among the top 3.8% of law firms nationwide, underscoring our continued commitment to excellence, client service, and leadership in one of the most complex and highly regulated areas of law.

We are honored to be recognized and remain committed to delivering exceptional counsel, strategic solutions, and unmatched experience across the FDA regulatory landscape.

FDA recently published draft guidance explaining how medical gas manufacturers should comply with new regulations that become effective today, December 18, 2025. As an early gift for the holidays, the industry is getting its own set of Current Good Manufacturing Practices (cGMPs). These cGMPs were first unveiled when FDA published a final rule in June 2024, so the medical gas industry got to peek at its presents before they are formally unwrapped today. While the cGMPs are now in effect, comments on the draft guidance are open until January 30, 2026.

Medical gases include both designated medical gases (oxygen, nitrogen, nitrous oxide, carbon dioxide, helium, carbon monoxide, and medical air that meet USP standards) and other FDA-approved gases, gas mixtures, and combination products used for therapeutic purposes. The medical gas supply chain extends from original manufacturers who produce the gas to transfillers who transfer finished medical gas from one container to another. The guidance addresses challenges similar to some of those faced by the drug industry like filling errors and container integrity, but in a light that highlights the unique ways those problems affect the medical gas industry.

The new regs are needed because of these differences, and because over the years, FDA has received several reports of medical gas errors that resulted in patient deaths and serious injuries. As nursing homes and hospitals are not required to report adverse events associated with medical gas mix-ups to FDA, the agency believes that the real toll of these errors is higher.

Prior to the new regulations and draft guidance, medical gas makers followed 21 CFR §§ 210 and 211, as do manufacturers of finished drug products. The 2024 Federal Register notice explained that as of today, the newly minted 21 CFR § 213 replaces Parts 210 and 211 for these products. FDA designed Part 213 for the specific ways companies make, package, refill, and store medical gases and their containers. Companies produce these gases in closed pressurized systems. The gases themselves don’t chemically degrade under normal storage, though manufacturers may still apply expiration dates when required by specific drug applications or when they choose to guarantee container integrity for a defined period.

What distinguishes Part 213 from the drug CGMP container provisions under Part 211? As these provisions are entirely specific to medical gas makers, the new regulations release the industry from the burden of trying to fit the square-peg needs of their industry into the round-hole regulations that weren’t written for them. Part 213 addresses the unique and specific ways companies actually manufacture these products without necessarily sacrificing quality, patient safety, or efficacy. For example, you’d never hear this about traditional drugs, but the guidance clarifies that outdoor spaces and delivery truck beds can serve as appropriate areas for certain operations.

Additionally, manufacturers reuse containers many times. The guidance clarifies best practices for supplier qualification, container leak prevention, facility maintenance, labeling controls, and handling returned cylinders. The industry had previously struggled with these issues under regulations written for traditional drugs.

FDA also established Part 230 for certifying designated medical gases that meet USP standards. Congress created this category because these seven gases predate FDA’s drug approval system. Before Part 230, manufacturers faced a regulatory paradox: they had to comply with drug regulations but couldn’t submit traditional drug applications for these gases, which have been in widespread medical use since before the Second World War. Part 230 solves this by providing a streamlined certification path that acknowledges that the discovery of new kinds of adverse events is unlikely while also bringing them under oversight specific to the industry. FDA exempted these gases from periodic safety reporting since new safety issues rarely emerge, but companies must report serious adverse events within 15 calendar days when those events meet reporting criteria.

FDA defines “medical gas manufacturer” broadly, capturing the potentially long supply chain. The definition includes any entity that produces gas by chemical reaction, physical separation, air compression, purification, or combining gases. This covers original manufacturers through downstream entities that manufacture, process, pack, or hold medical gases.

The industry has advocated for these changes since the 1970s, and these new rules have been in the offing since Congress ordered FDA to write medical gas regulations in 2017. Some years, holiday presents are worth waiting for.

FDA has authorized more than 1,200 artificial intelligence (AI)-based digital devices for marketing. To date, none of these has been indicated to address mental health. Currently there are 57.8 million adults who have a diagnosed mental illness and many do not have access to high quality and effective treatments. The use of generative AI digital devices, such as chatbots and virtual companions could close the gaps for those in need of mental health services. Recognizing the growing demand for “AI therapists,” the November meeting of FDA’s Digital Health Advisory Committee focused on FDA’s regulatory approach for generative artificial intelligence-enabled digital mental health medical devices, taking into consideration their benefits, risks to health, and risk mitigations, including premarket evidence and post market monitoring.

Generative AI is defined as an AI model that “emulates the structure and characteristics of input data in order to generate derived synthetic content.”  The goal of generative AI is to create content that mimics a human providing a more personalized experience for the user. Generative AI can create original digital content, including  video, audio, or text.

The Advisory Committee identified several potential benefits to generative AI devices, including its use in triaging patients, enabling more immediate response to patients, expanding access to care in underserved areas, and enabling personalized treatment. The Advisory Committee also raised concerns about novel risks that could be introduced by generative AI devices, including bias, “hallucination” (when the model generates inaccurate or misleading results)  and  “sycophancy” (when the model seeks to please the user at the expense of accuracy). Without a healthcare professional’s oversight (human-in-the-loop), to identify errors and to detect patient cues missed by the device, generative AI devices could adversely affect a patient’s mental health rather than lead to improvement.

The Advisory Committee noted that there are many digital mental health technologies on the market today, including some that fall outside of FDA regulation, such as general wellness devices. General wellness devices that encourage healthy eating habits, track sleep, and guide meditation can be effective tools for those with and without a mental illness. This has created a source of confusion to users of those products who may not be aware of the difference between an FDA regulated device and a general wellness product.

Generative AI devices that treat or diagnose a psychiatric condition or substitute for a mental healthcare provider are the type of generative AI products which would fall under FDA’s purview. “Therapeutic” generative AI devices are those that are intended to aid in the treatment of a psychiatric condition. Today therapeutic mental health devices are usually used under the supervision of a healthcare provider. “Diagnostic” generative AI devices are those used in the assessment, evaluation, and diagnosis of a patient. Patients use diagnostic devices today to inform the healthcare provider’s diagnosis. There are non-AI digital mental health devices that have been authorized in diagnosis and treatment and most are for prescription use only.

The focus of the Advisory Committee was on determining the data and monitoring that should be required to establish a reasonable assurance of safety and effectiveness for these devices.

Speakers from FDA discussed the need for robust real-world evaluation strategies to ensure AI-enabled devices are safe and effective after deployment. They also noted the importance of a risk-based approach given the range of devices that may be introduced—from low risk general wellness applications to devices providing therapy for psychiatric disorders— and the level of autonomy of the device (with or without human oversight). FDA speakers proposed the inclusion of a predetermined change control plan (PCCP) and a performance monitoring plan in premarket submissions as potential strategies to mitigate risks arising from changes in AI-enabled software performance over time, and use of double blind, randomized, placebo controlled trials to mitigate risks associated with placebo response in patients with psychiatric disorders.

Stakeholders presented a variety of perspectives to the Advisory Committee on the benefits and risks of generative AI mental health devices and recommended evidence that should be generated to support their use. They identified increased access to mental health treatment as a key benefit of the technology, as many patients with mental health conditions are unable or unwilling to obtain diagnosis and/ or treatment from a healthcare professional. Stakeholders also noted that generative AI-based tools could have higher empathy—some models have shown effectiveness of generative AI in decreasing loneliness and restoring relationships— and reduced cost as compared to traditional human based provider care.

The committee discussed risks and challenges of using LLMs (large language models) including misdiagnosis, especially given overlap of symptoms across mental health disorders; misuse and over reliance; adverse impact on vulnerable populations or on patients with psychosis; bias; and ethical dilemmas involving data privacy and consent.  They proposed a variety of risk-mitigation guard rails, such as:

• Human oversight and appropriate training;
• Transparency that the output is from AI;
• Access to emergency services;
• Verification and validation, including randomized clinical studies;
• Limiting the device to prescription use only;
• Considering Class III designation; and
• Need for post market monitoring.

The committee deliberated on what additional mitigations may be required for over-the-counter (OTC) use. For OTC use, panelists were concerned that patients could self-diagnose and select an appropriate application based on their level of illness. They also felt strongly that a clinician should be in the loop and available to act in an emergency and to identify adverse events.

The committee also discussed the use of such technology for pediatric patients. One committee member noted that some of the mental health crisis is related to smart phone applications that have been inappropriately regulated with no consequence and was concerned with use of another app to address the problem, with the risk that the mental health app could be addicting itself. For pediatric use, committee members were so concerned that they did not know what to say. The committee discussed the need to ensure the device is developed for a specific age group and there may be different approaches required for use by a child vs an adolescent. Education and training for parents, patients, and healthcare providers were especially important for the pediatric population.

Surprisingly, FDA did not have many questions for the committee. They noted that there is a request for comments on AI-enabled Medical Devices, which we previously blogged about here.

This advisory committee meeting highlighted challenges for digital therapeutics for mental health as well as generative AI. Paired together, there are a number of challenges that both FDA and developers will need to carefully navigate to ensure safeguarding for patients. Digital mental health devices are as complex as the patient population they are intended to help and ensuring reasonable assurance of safety while promoting innovation will require regulatory approaches focused on total product lifecycle balancing pre and post market regulatory requirements.

The first days of December have been marked by an unusual burst of activity related to OTC drugs at FDA.

Request for Information for 2026 Meeting

As previewed by former CDER Director Tidmarsh at the Consumer Healthcare Products Association meeting in September, FDA announced last week its intent to schedule a public meeting in 2026 on increasing access to nonprescription (OTC) drugs. In preparation for the meeting, FDA issued a request for information inviting interested parties and the public (specifically including commercial drug developers, health care providers, and consumers) to share their perspectives on scientific, regulatory, and practical considerations related to nonprescription drug use.

The request includes specific questions for which FDA is seeking input that will be used to inform topics for the 2026 public meeting. The questions listed below are described as being “most pertinent to increasing access to nonprescription drugs.”

1. What are challenges faced in the development of drugs for nonprescription use?
2. What are the biggest opportunities to improve access to nonprescription drugs?
3. How could interested parties— including, but not limited to, drug developers, health care providers, patients, consumers, and retailers— work together to increase access to safe and effective nonprescription drugs?
4. Looking ahead to a 2026 public meeting, what specific topics or questions would you like to see on the agenda for public discussion?
5. What scientific barriers most limit progress in increasing access to nonprescription drugs?
6. What additional scientific tools, technologies, or data sources could support access to nonprescription drugs?
7. Are there specific diseases or conditions that have not, traditionally, been treated with nonprescription drugs for which nonprescription drugs could be safely and effectively used without the supervision of a licensed healthcare practitioner? If so, what information would support such use under the applicable statutory and regulatory requirements for nonprescription drugs?

In the past five-plus years, two programs have been introduced that were designed, at least in part, to increase access to OTC drugs. The first was under OTC Monograph Reform enacted in the 2020 CARES Act which includes a process for adding ingredients or new uses to the monographs through the submission of an OMOR (over-the-counter monograph order request) (read our blog here), and the second was the final rule for ACNU to allow for the approval of an OTC drug with “additional conditions of nonprescription use” beyond the information found in the drug facts label (DFL) (read our blog on ACNU here).  Although the final ACNU rule issued in January 2025 only became effective in May of this year, and the OMOR process was expected to take some time to get up and running, the lack of increase in OTC options under these programs and the generally low numbers of OTC switches in recent years may be a factor the Agency’s decision to hold this meeting.  It will be interesting to see whether commenters provide implementable suggestions for increasing access to nonprescription drugs or primarily describe frustrations with the current programs, and what FDA does with the comments and, eventually, the meeting itself.

The comment period closes on February 2, 2026.

New MaPP for ANDAs of a Switched NDA

This week FDA issued a new Manual of Policies and Procedures (MaPP) for when a reference listed drug (RLD) undergoes an OTC switch from prescription to nonprescription status. MaPP 5200.11, entitled “Prescription to Nonprescription Switches and Abbreviated New Drug Applications,” applies only to full Rx-to-OTC switches. The MaPP describes that in this situation, ANDAs referencing the now-switched NDA must update labeling with the relevant changes and that FDA does not consider the full Rx-to-OTC product approved through a supplement to the original Rx NDA to be a different listed drug. Consequently, ANDA holders referencing that NDA can submit a supplement (rather than a new ANDA) to update labeling to reflect the OTC status of the RLD.

The MaPP goes on to set forth timelines for FDA to take certain actions following the switch. Specifically, it provides that FDA will notify the ANDA holders and track whether ANDA holders address the change with the submission of a supplement or withdrawal of the ANDA or other correspondence regarding the intended action and timeline. If no action is taken within six months, a follow-up notification will be sent and if there is no response within 30 days, the Office of Compliance is to be consulted.

Priority Review Vouchers (PRV) are incredibly valuable—several have sold for hundreds of millions of dollars.  Which is why it makes sense that Sun Pharma Advanced Research Co. Ltd. and Sun Pharmaceutical Industries, Inc. went to the mat fighting FDA for a PRV for phenobarbital.  And last week, that fight was rewarded by the District Court for the District of Columbia, which found that FDA’s refusal to award a PRV was unlawful under the Administrative Procedure Act based on the definition of the word “approved.”

For the uninitiated, a PRV is a voucher that can be redeemed for Priority Review on a subsequent application.  Use of the voucher therefore reduces the PDUFA goal for a non-Priority Review eligible application from 10 months to 6 months.  A PRV can be awarded for a statutorily-enumerated tropical disease or, relevant here, a rare pediatric disease approved before September 2026 (there used to a Medical Countermeasure PRV, but that has lapsed).  In order to be eligible for a rare pediatric disease PRV, the application must be for the prevention or treatment of a rare pediatric disease, submitted under section 505(b)(1) of the FDC Act, approved between September 30, 2016 and September 30, 2026, based on clinical data from a study evaluating pediatric populations and dosages without an adult indication, and eligible for priority review.   Integral to the issue at hand here, the application also must seek approval for “a drug . . . that contains no active moiety . . . that has been previously approved in any other application under subsection (b)(1), (b)(2), or (j) of section 355 of this title.”

Back to the action: The fight starts in November 2022, when Sun received approval for SEZABY (phenobarbital) to treat neonatal seizures.  But in approving SEZABY, FDA informed Sun that it denied Sun’s request for a rare disease PRV.  FDA denied the PRV on the basis that SEZABY “is not an application for a drug ‘that contains no active moiety . . . that has been previously approved in any other application under subsection (b)(1), (b)(2), or (j) of section 505’ of the FD&C Act.”   FDA pointed to NDA 000597 for phenobarbital and atropine as the basis of denial, noting that the Agency had “identified at least one NDA for a drug product containing phenobarbital as an active moiety that came into effect before 1962 and was deemed approved by the 1962 Amendments.”

Importantly, the phenobarbital NDA referenced by FDA, NDA 000597, was submitted in 1939, when section 505 of the FDC Act provided that an NDA would automatically become effective unless a contrary order were issued; as the Court explained, the NDA “became effective not by any positive agency action but by its inaction.”  In 1962, Congress amended the FDC Act to require affirmative agency approval based on evidence that showed the drug is effective; applications that previously became effective under the Act were “deemed” approved by FDA, allowing them to continue to be marketed unless FDA ordered its removal after two years for lack of efficacy.  In 1972, FDA determined that there was a lack of substantial evidence to support effectiveness of the phenobarbital drug, proposed to withdraw NDA 000597 in 1977, and formally withdrew approval in 1982.

Based on these facts, Sun argued that NDA 000597 was not an application under section 505(b)(1), (b)(2), or (j) of the FDC Act because those provisions did not exist in 1939.  But even if it were an application, Sun argued, the application was not “approved” as Congress contemplated under the plain language of the statute.   The word “approved” requires affirmative review, which did not apply to phenobarbital, as it was automatically approved by FDA inaction and later only “deemed” approved.

FDA, on the other hand, argued that NDA 000597 was an “application under subsection (b)(1)” precisely because it was deemed approved under the 1962 amendments.  And, because it was “deemed” approved, the application is approved, according to FDA.  Thus, since phenobarbital was one of the active moieties in approved NDA 000597, FDA contended that the active moiety had been previously approved by FDA and not entitled to a PRV.

The Court sided with Sun.  Because FDA did not ““sanction officially” phenobarbital, or “confirm [it] authoritatively,” or “accept [it] as satisfactory,” and because it was only “deemed” approved and later withdrawn for lack of efficacy, the Court said, “[i]n no ordinary sense then was NDA 000597 ever ‘approved.’”  By cross-referencing the 1984 Hatch-Waxman Amendments that introduced the modern-day 505(b) and (j) approval pathway, the Court explained that “Congress clearly signaled that any ‘previous approval’ had to have successfully navigated” the modern-day application process.  Finally, the Court found that FDA’s interpretation conflicted with the purpose of the rare pediatric PRV: Congress could not have intended a drug that “was never able to show efficacy and was ultimately pulled from the market to erect an obstacle to future developments in the treatment of rare pediatric diseases.”

This decision is meaningful—both in the context of rare pediatric diseases and beyond.  It opens up grandfathered drugs to be eligible for a very valuable PRV if they are repurposed for a pediatric or tropical disease.  While that is interesting, it is relevant to a very small number of drugs.  Nevertheless, the decision has serious implications beyond the world of PRVs:  effectively, the decision will force FDA to reexamine the definition of a “new” drug in any context in which the active moiety cannot have been previously “approved.”   Specifically, this is important from an NCE context, as FDA previously has interpreted NCE to apply only to drugs that have never been approved, searching its records all the way back to 1938.   Presumably, this leaves FDA’s interpretation vulnerable to challenge, as drugs “approved” between 1938 and 1962 were not necessarily “approved.”   We’re watching to see whether someone—maybe even Sun—takes this to court to obtain an NCE period for a pre-1962 drug.

At this point in 2024, there were countless unknowns about how the medical device industry would be impacted in 2025.  Did the year unfold as you expected?  Did your company prepare for impacts to the foreign supply chain?  Did you predict the government was going to shut down for 43 days?  What lessons have we learned to take into 2026?

Please join us at 11:00 am today, December 10, 2025, for a webinar tailored to medical device professionals: attorneys, regulatory experts, and compliance staff.  HPM attorneys Anne Walsh and Steven Gonzalez will present the key developments that affected the medical device industry in 2025, highlight notable trends from the data, and read the tea leaves for what to expect in 2026.  Don’t miss this free webinar.

Register here.

On December 5, FDA’s Digital Health Center of Excellence announced the “Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot,” in conjunction with the Center for Medicare and Medicaid Innovation (CMMI) Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) model. FDA’s press release states that TEMPO is a “voluntary pilot designed to promote access to certain digital health devices while safeguarding patient safety.”

TEMPO will use a “risk-based enforcement approach that supports digital health devices intended for use to improve patient outcomes in cardio-kidney-metabolic, musculoskeletal, and behavioral health conditions.” The devices in the TEMPO pilot must be for uses “covered by the CMMI ACCESS model while collecting, monitoring, and reporting real-world performance data.” The ACCESS model intends to address a current challenge faced by developers of many digital health products, namely, that these products have not historically been covered by CMS, minimizing, if not entirely precluding, their uptake. ACCESS will allow CMS to offer coverage based on “outcomes over activities, enabling clinicians to offer innovative technology-supported care that improves patients’ health and complements traditional care.”

There are a few points of particular interest in this announcement. First, FDA states:

Under this approach, participating manufacturers may request that the FDA exercise enforcement discretion for certain requirements, such as premarket authorization and investigational device requirements, while manufacturers collect and share real-world data demonstrating the device’s performance. The FDA will work with participants in the TEMPO pilot to identify the circumstances when enforcement discretion may be appropriate for that manufacturer’s device.

It is not clear how a manufacturer would go about requesting enforcement discretion, the circumstances in which FDA would find it appropriate to exercise such discretion, or what happens after the manufacturer is done collecting and sharing “real-world data demonstrating the device’s performance.” Would the manufacturer, at that point, have to go back and obtain a premarket authorization? This would be an extraordinarily odd outcome, if the device is already being reimbursed by CMS, utilized for clinical decision-making, and essentially used commercially as if it were already authorized. This also does not address whether FDA would exercise enforcement discretion for other related requirements, for example, registration and listing and quality system requirements. It also is worth pointing out that it is not clear whether FDA has the statutory authority to permit differential treatment of certain devices, allowing some on the market without premarket authorization while requiring similar devices that are not part of the program to obtain premarket authorization before commercialization.

Relatedly, while not necessarily clear on FDA’s website, CMS’s website more explicitly calls out the types of conditions that devices in the pilot should be intended to treat, namely:

• Early cardio-kidney-metabolic conditions (eCKM): hypertension (high blood pressure), dyslipidemia (high or abnormal lipids, including cholesterol), obesity or overweight with marker of central obesity, and prediabetes
• Cardio-kidney-metabolic conditions (CKM): diabetes, chronic kidney disease (3a or 3b), and atherosclerotic cardiovascular disease, including heart disease
• Musculoskeletal conditions (MSK): chronic musculoskeletal pain
• Behavioral health conditions (BH): depression and anxiety

The first category above is particularly interesting, given FDA’s recent pushback on any blood pressure product that has not been cleared by FDA, stating that without such clearance there is no assurance of safety and effectiveness. See our posts on the WHOOP Warning Letter and FDA’s recent safety alerts regarding risks associated with use of unregulated blood pressure monitors. FDA now seems to be saying that products of this type may not need premarket authorization, at least not if they are part of this pilot program, which seems to call into question FDA’s prior statements about the necessity of such oversight to assure safety and effectiveness.

Given the historical challenges associated with coverage of digital health products, the TEMPO pilot is an overdue initiative and one with the potential to help provide access to critical digital health products for the Medicare population. In order to allow interested parties to proceed appropriately, however, additional clarification is needed. For example, it is not clear whether a party needs to submit both a “statement of interest” to the FDA, as indicated in the announcement, as well as an “ACCESS Model Interest Form” to CMS, or whether submission of one is adequate. It is also not clear whether CMS would need to first determine that the device is eligible for coverage under the ACCESS Model prior to the device being considered for the TEMPO pilot, or whether such a determination will be made collaboratively between CMS and FDA. Furthermore, it may be helpful for FDA to update its page to more specifically identify the conditions to be treated by a device in the pilot and mirror what is on CMS’s website, indicated above.

CMS’s website also states that the ACCESS Model Interest Forms must be submitted before April 1, 2026, and the program is intended to begin in July 2026. While FDA’s announcement indicates that interested parties can submit “statements of interest” beginning in January 2026, it does not include the April 1 deadline, nor does it indicate an intent to begin the program in July. Given that ACCESS and TEMPO are intertwined, it is reasonable to assume that these dates apply for both parties.

We are happy to help you keep up your “tempo” to be able to “access” both initiatives in a timely manner.

A few months ago, we blogged about a Texas U.S. District Court’s Wulferic ruling that FDA’s civil monetary penalty (CMP) provision for tobacco products contained at 21 U.S.C. § 333(f)(9) is unconstitutional under the Seventh Amendment and SEC v. Jarkesy, 603 U.S. 109 (2024). Wulferic, LLC v. FDA, 793 F. Supp. 3d 830 (N.D. Tex. 2025).  (As a recap, the court, applying Jarkesy, ruled that the Seventh Amendment right to a jury trial applies to civil monetary penalties like those applied by the FD&C Act, and that the enforcement of these penalties by administrative law judges is unconstitutional.)  We also considered the potential implications of that ruling, and its place in the broader landscape of Jarkesy challenges to FDA’s tobacco CMPs.  Nearly four months on, the picture is coming into focus: the main action is now shifting to the D.C. Circuit and the Fifth Circuit, and with FDA going full steam ahead on pursuing tobacco CMPs and defending its position, the stakes remain high.

In September, FDA appealed the Wulferic decision and filed a brief in the Fifth Circuit case we were watching, Texas Tobacco Barn, forcefully defending the constitutionality of its tobacco CMP provisions.  The Fifth Circuit then decided to stay the Wulferic appeal pending the outcome of Texas Tobacco Barn, although the Wulferic petitioner (likely wanting to get a word in while it matters most) filed an amicus brief there.  See Wulferic, LLC v. FDA, No. 25-11112, Dkt. No. 18 (5th Cir. Oct. 10, 2025); Texas Tobacco Barn, LLC v. HHS, No. 25-60200, Dkt. Nos. 43, 44 (5th Cir. Aug. 3, 2025).  Texas Tobacco Barn is fully briefed, but no argument has yet been scheduled.

We were also keeping an eye out for a ruling in The Vaping Dragon, which presented a different judge in the Northern District of Texas with the same issues as Wulferic.  That judge has still not issued any ruling — although that case has not been formally stayed, it is possible that the judge too is keeping his pen dry until the outcome of the Fifth Circuit’s decision(s).

Over in the D.C. Circuit, things are moving a bit more speedily in the case we were watching there.  Much the same as in Texas Tobacco Barn, in D and A, FDA filed a brief forcefully defending its tobacco CMP provisions.  The D.C. Circuit has set oral argument for December 8, 2025 (we’ll be tuning in), offering the first chance for the Circuit courts to weigh in on this precise issue.  See D and A Business Invs., LLC v. FDA, No. 25-1074 (D.C. Cir. Sept. 12, 2025, Oct. 16, 2025).  While Texas Tobacco and D and A each present other challenges to the proceedings such that they theoretically could be resolved without reaching the Jarkesy question, in all likelihood, both Circuits will reach its merits.

As before, the stakes are high: a ruling from either court that FDA’s tobacco Civil Money Penalty proceedings are unlawful could significantly dismantle FDA’s arsenal of actions to enforce compliance with the FD&C Act’s tobacco provisions.  And even if such a ruling only purports to offer party-specific relief (as the district court Wulferic decision did), FDA would be much harder-pressed to continue business as usual given the broader precedent set by such a decision.  If the challengers lose either case, they will be highly motivated to seek review in the Supreme Court; and especially if the outcome of the two decisions results in a Circuit split, the Supreme Court will likely weigh in to resolve it (as it recently did in a series of challenges to FDA decisions on flavored e-cigarette tobacco marketing applications, see FDA v. Wages & White Lion Invs., 604 U.S. 542 (2025) (see our post here)).

At least so far, however, FDA’s CMP proceedings show every sign of proceeding apace even after the (limited) Wulferic loss: FDA records show that it has continued to file hundreds of new administrative CMP complaints in recent months, just as it did before. See FDA, Tobacco Compliance Check Outcomes.

We will continue to monitor the developments in these cases and any other major challenges that may arise; but for now, what goes on in the federal appeals courtrooms in the District of Columbia and then New Orleans will matter most.

FDA has announced a public meeting and request for comment on proposed recommendations for the next reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years 2028 through 2032. BsUFA allows FDA to collect user fees to support the review of biosimilar biological products. The current authority expires in September 2027, and new legislation will be needed for FDA to continue collecting these fees.

BsUFA was first enacted in 2012 and has been renewed twice since then. The program is designed to give FDA additional resources—such as staffing—to help ensure efficient and predictable biosimilar application reviews. Under each reauthorization, FDA and industry agree to specific performance goals and procedures, including timelines for reviewing applications and commitments related to meetings, communication practices, and regulatory science efforts. The current BsUFA (BsUFA III) includes enhancements such as new supplement categories, review timelines, expanded support for interchangeable biosimilars, improved inspection communication, and investments in IT and data modernization.

As part of the reauthorization process for BsUFA IV, FDA is seeking public input before it begins negotiations with industry. FDA is specifically interested in feedback on the performance of the current BsUFA program, which elements should be kept, changed or discontinued, whether any new components should be added, and whether the current fee structure should be updated to better support biosimilar development and timely patient access.

The public meeting will be held on December 3, 2025, from 9 a.m. to 12 p.m. EST, both in person at FDA’s White Oak Campus and virtually. After the meeting, FDA will continue to accept written comments until January 2, 2026. A transcript of the meeting and all submitted comments will be posted online once available.

Stay tuned for further updates.

Hyman, Phelps & McNamara, P.C. (HPM) is pleased to announce that Steven Gonzalez has been promoted to Counsel.

Steven joined the firm in 2022 and has quickly become a trusted advisor to clients navigating complex FDA regulatory and compliance matters. His practice focuses on advising pharmaceutical and medical device manufacturers on a wide range of issues, including product development strategy, marketing and promotion, lifecycle management, and enforcement risk. Steven’s full biography can be found here.

HPM Director Anne Walsh noted “Steven’s expertise and judgment on medical device topics make him a go-to resource for firm clients and an invaluable team member at HPM.  I am thrilled that he is being promoted in recognition of his substantive contributions and potential.”

Please join us in congratulating Steven on this well-deserved achievement.

On January 31, 2024, FDA issued the final rule revising 21 C.F.R. Part 820, which, upon taking effect, will be referred to as the Quality Management System Regulation (QMSR) (see our prior blog post here).  The QMSR incorporates the international standard ISO 13485: 2016 Medical devices — Quality management systems — Requirements for regulatory purposes by reference and came with a two-year transition period and effective date of February 2, 2026.  The Agency has said little about its transition during the past two years, but on October 27, 2025, just months from implementation of the QMSR, FDA has issued its first draft guidance, Quality Management System Information for Certain Premarket Submission Reviews (Draft Guidance).

The Draft Guidance provides recommendations for QMSR information included in Premarket Approval (PMA) and humanitarian Device Exemption (HDE) application.  While of obvious importance to those working on PMAs and HDEs, the recommendations in the Draft Guidance also shed light on how FDA may be interpreting ISO 13485 and how it may review quality system information in future inspections.

There is a lot of overlap between the requirements of ISO 13485 and the current Quality System Regulation (QSR), which is being replaced by the QMSR.  One of the key differences between the current Quality System Regulation and ISO 13485 is the requirement in ISO 13485 to “apply a risk based approach to the control of the appropriate processes needed for the quality management system” ISO 13485: 2016, Subclause 4.1.2(b).  The Draft Guidance recommends submitters provide “a summary of the risk-based approach(es) used to control the processes that make up the organization’s QMS.” Draft Guidance at 7.  Thus, when updating the quality system for the QMSR, it will be important to not only ensure each procedure covers the specific requirements of ISO 13485, but also to ensure that the overarching risk-based approach used in developing the system is documented.

The Draft Guidance, when finalized, will supersede the current guidance, Quality System Information for Certain Premarket Application Reviews, issued February, 2003 (Current Guidance).  Despite more than 20 years, the overall content expected is not changing drastically.  The Draft Guidance presents the recommended information for a PMA or HDE in the order it is described in ISO 13485 and uses the terminology used in ISO 13485, which is not always the same as was used in the QSR.  A marketing application should include a full description of the documentation described in ISO 13485 for:

• Management responsibility, including responsibilities of top management;
• Resource management, including infrastructure requirements and requirements for the work environment and contamination control;
• Product realization, including development processes, design and development requirements, purchasing requirements, purchasing process requirements, purchasing information requirements, requirements for verification of purchased product, implementation of production and service provisions, and control of monitoring and measuring equipment; and
• Measurement, analysis, and improvement, including the processes for monitoring and measurement, control of nonconforming product, analysis of data, and identifying and implementing necessary changes.

For requirements of the QMSR that are not directly from ISO 13485, the Draft Guidance also provides recommendations for content in the marketing application.  These include requirements for unique device identification (UDI), traceability and medical device tracking, medical device reporting, reports for corrections and removals, control of records, and device labeling and package controls.  One item of note is that the Draft Guidance recommends the marketing submission include a “sampling of UDIs and Global Unique Device Identification Database (GUDID) records” whenever possible. Id. at 20. As a FDA Premarket Submission Number is required for obtaining a GUDID account and submitting data on the device, this will unlikely be available for original submissions.

One final point of interest in the Draft Guidance is the inclusion of a Guidance History table on the last page.  It includes a note that the “table was implemented, beginning October 2025, and previous guidance history may not be captured in totality”.  For the description of the revisions, it says to “See Notice of Availability for more information” and includes a link to the FDA guidance document webpage.  The Notice of Availability provides high level statements regarding the reason for the Draft Guidance, but does not provide information on the specific differences as compared to the Current Guidance.  Given the lack of any useful information, it is not clear why the table is being included.

Those wishing to submit comments on the Draft Guidance, should do so by January 16, 2026.

As the February 2026 effective date for the QMSR approaches, FDA’s release of the Draft Guidance offers long-awaited insight into how the Agency may operationalize its alignment with ISO 13485. While the core expectations for PMA and HDE submissions remain largely consistent with prior guidance, the shift in structure, terminology, and emphasis on a documented risk-based approach signals a meaningful evolution in FDA’s regulatory posture. Given this, all medical device manufacturers, not just those with planned PMAs or HDEs, should consider the Draft Guidance as any quality system updates are being made for compliance with the QMSR.

Hyman, Phelps & McNamara, P.C. (HPM) is hosting a complimentary webinar, titled “Medical Device Update, 2025 Year in Review.” The webinar is scheduled for December 10, 2025 (11:00am to 12:00pm ET).

Don’t miss this essential briefing. Our experts will unpack the year’s top FDA regulatory changes, enforcement trends, and strategic insights to help medical device companies navigate what’s coming next.

The webinar will feature HPM attorneys Anne Walsh and Steven Gonzalez. You can register for the complimentary webinar here.  After registering, you will receive a confirmation email containing information about joining the webinar.