• where experts go to learn about FDA
  • Adrienne R. Lenz, Principal Medical Device Regulation Expert

    • Mastering Responses to FDA 510(k) AI Letters: A Strategic ApproachJuly 10th, 2023

      It takes a significant amount of time, cost, and effort to prepare a premarket notification 510(k) submission.  But that is only the beginning.  After a firm submits a 510(k) to FDA, FDA will request still more information after a first-pass review.  According to the 2nd …

    • The Good, Bad, and Ugly side of 510(k)s—HP&M’s Early Experience with the eSTAR Template for 510(k)s: Part 2March 8th, 2023

      As we discussed in our prior post, the electronic Submission Template And Resource (eSTAR) template will take getting used to in terms of form.  It is also going to take some getting used to in terms of process.  As most in the device industry know, …

    • The Good, Bad, and Ugly side of 510(k)s—HP&M’s Early Experience with the eSTAR Template for 510(k)sMarch 1st, 2023

      Since 2005, 510(k) submissions have been formatted according to FDA guidance Format for Traditional and Abbreviated 510(k)s.  The guidance describes twenty sections to be included in a Traditional or Abbreviated 510(k).  With 18 years’ experience, we have developed a pretty good system for preparing 510(k) …

    • So Much More than Just Paperwork – The Importance of Design Controls for Device Start-upsFebruary 7th, 2023

      For medical device start-up companies, understanding and successfully navigating applicable FDA regulations and requirements is an important part of the path to market.  For founders new to the medical device industry, especially with device types that are often considered novel, the learning curve can be …

    • CDRH’s Plan to De-risk the Medical Device Valley of DeathNovember 21st, 2022

      As was introduced in our recent blog post summarizing the 2022 MedTech conference (here), FDA’s Center for Devices and Radiological Health (CDRH) recently announced the launch of a new pilot program, the Voluntary Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot (see announcement attributed …

    • FDA’s Pre-Cert Pilot Ends. Will there be a Sequel?November 1st, 2022

      FDA began the Software Precertification (Pre-Cert) pilot program in 2017 to evaluate an alternative approach to regulation of software as a medical device (SaMD) over the total product lifecycle (TPLC).  We have followed it over the last five years, with blog posts here, here, here, …

    • (Slightly More) Options for cGMP for Combination Products: FDA Describes Alternative or Streamlined Mechanisms for ComplianceSeptember 26th, 2022

      FDA recently published Alternative or Streamlined Mechanisms for Complying with the Current Good Manufacturing Practice Requirements for Combination Products; List under the 21st Century Cures Act in the Federal Register (FR Notice).  By way of background, 21 C.F.R. § 4.3 requires generally that manufacturing of a …

    • Choice of Secondary Predicate versus Reference Devices in a 510(k) SubmissionSeptember 13th, 2022

      It’s been almost 11 years since FDA first clarified use of multiple predicate devices and introduced the concept of Reference Devices in the draft guidance titled The 510(k) Program:  Evaluating Substantial Equivalence in Premarket Notifications [510(k)], which we blogged about here.  The final guidance with …

    • Keeping the Patient in the LoopJanuary 20th, 2022

      Closed-loop control systems, which adjust device output based on information received from a sensor to keep a variable at a reference position, are common in many medical devices.  There are numerous examples where device output is controlled to maintain a physical measurement, such as pressure, …

    • Assessing the Credibility of Computational Modeling and Simulation in Medical Device SubmissionsJanuary 3rd, 2022

      On December 23, 2021, CDRH released as a draft guidance, Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions (Draft Guidance).  Computational modeling and simulation (CM&S) can sometimes be useful to demonstrate the safety and effectiveness of medical devices or incorporated into …

    • Submitting a 510(k)? Keep Hoarding Blank CDsNovember 9th, 2021

      FDA introduced electronic copies (eCopies) of 510(k)s in 2013 (see our prior blogs here and here) as a way to reduce the need for submission of paper copies of 510(k)s to the Agency.  An eCopy is an electronic copy of the 510(k) that is comprised …

    • FDA Introduces Biocompatibility Assessment Resource CenterMarch 24th, 2021

      Over the past several years, FDA has faced criticism stemming from high-profile device issues related to materials, including the Essure permanently implanted birth control device and metal-on-metal hip implants. Given this, it is not surprising that device biocompatibility has received greater focus in FDA premarket …

    • FDA Continues Discussion of AI/ML Software Medical DevicesJanuary 21st, 2021

      On January 12, 2021, FDA issued an Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan (“AI/ML Action Plan”) and a discussion paper on their Proposed Regulatory Framework for Modification to Artificial Intelligence/Machine Learning (AI/ML) – Based Software as a Medical Device …

    • FDA Finalizes Guidance on Obtaining Agency Feedback on Combination Products; Highlights Best Practices for Meeting and Communicating with FDADecember 14th, 2020

      On December 4, 2020, FDA finalized the guidance document, Requesting FDA Feedback on Combination Products (Guidance), which was issued to fulfill the requirement under Section 3038 of the Cures Act.  As a reminder, Section 3038 contained several provisions to help facilitate FDA engagement and appropriate …

    • FDA Launches Digital Health Center of ExcellenceSeptember 25th, 2020

      On September 22, FDA announced the creation of a Digital Health Center of Excellence (DHCoE), which has grown out of their existing Digital Health Program.  The objectives of the DHCoE include connecting and building partnerships, sharing knowledge and innovating regulatory approaches related to digital health.  …