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  • Medical Devices

    • Pharmacogenetic Tests: Recent FDA Authorization for One and Warnings about OthersNovember 21st, 2018

      On October 31, 2018, FDA announced that 23andMe could market its Personal Genome Service Pharmacogenetic Reports test (the “23andMe test”) as a direct-to-consumer test for providing information about genetic variants that may be associated with medication metabolism.  The 23andMe test was reviewed using the de …

    • Is Your 510(k) Device a Combination Product?November 19th, 2018

      Earlier this year, FDA quietly made changes to their 510(k) clearance letters related to combination products cleared via the 510(k) pathway. The letters now include the following language (new text in bold italics): Although this letter refers to your product as a device, please be aware …

    • FDA Proposed Rule Allows Waiver of Informed Consent If IRB Finds Risk Is MinimalNovember 15th, 2018

      The informed consent requirements in drug and device trials are important for subject protection. But there are trials where it is not possible (or difficult) to obtain consent, and the risk to subjects is minimal. Until recently, these trials could not go forward. In the 21st …

    • Recruiting Class of 2018 – HP&M Adds Three New Attorneys and Two Regulatory ProfessionalsNovember 8th, 2018

      It’s been a busy year at Hyman, Phelps & McNamara P.C. as we’ve added three new attorneys and two regulatory professionals to our ranks.  The five professionals collectively add depth and breadth to our practice with FDA and industry experience. Deborah L. Livornese joined HP&M as …

    • May FDA Regulate Medical Devices As If They Were Drugs?November 8th, 2018

      In the world of FDA, there is a stark divide between the regulatory treatment of drugs and medical devices. A product intended to diagnose or treat disease, or to alter the structure or function of the body, is within the definition of a drug under …

    • HP&M Weighs in on FDA’s “Technical Assistance” to Proposed IVD LegislationNovember 2nd, 2018

      It’s been about two months since FDA issued its Technical Assistance (TA), and the buzz around FDA’s draft legislation has not died down. In fact, FDA has continued to promote the proposal, including a speech by Commissioner Gottlieb’s Chief of Staff, Lauren Silvas, in late …

    • Cybersecurity Déjà VuOctober 31st, 2018

      On October 18, FDA issued a new draft guidance document, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (“Draft Guidance”). When final, it will supersede the 2014 guidance document of the same name (“Current Guidance”). The guidance comes shortly after release of …

    • FDA Issues Two New Guidance Documents on Voluntary Consensus Standards, Consolidating and Replacing Earlier GuidanceOctober 30th, 2018

      On September 14, 2018, FDA issued two new guidance documents on voluntary consensus standards used in medical device premarket submissions: (1) a draft guidance titled “Recognition and Withdrawal of Voluntary Consensus Standards” (Draft Guidance); and (2) a final guidance titled “Appropriate Use of Voluntary Consensus Standards in …

    • CDRH Introduces Third 510(k) Pilot in Less than Two Months – This Time on OCT DevicesOctober 29th, 2018

      The Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) recently announced a new voluntary pilot program to streamline review of 510(k) submissions for ophthalmic optical coherence tomography (OCT) devices. OCT devices are devices that are used for viewing, imaging, measurement, and analysis …

    • If at First You Don’t Succeed, Try, Try, Try Again: FDA Issues Plan to Increase Efficiency of 510(k) Third Party Review ProgramOctober 12th, 2018

      Last month, FDA announced a plan for revamping the 510(k) Third Party Review Program (the “Program”), which was outlined in a publication, Eliminating Routine FDA Re-Review of Third Party 510(k) Reviews (the “Plan”). One element of the Plan includes the issuance of a draft guidance, …

    • Final Guidance Issued for Considering Benefit-Risk Factors in 510(k)s with Different Technological CharacteristicsOctober 5th, 2018

      On September 25, 2018, FDA issued a final guidance document: Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics (“guidance”).  A draft of the guidance was issued on July 25, 2014.  When reviewing device 510(k)s, FDA’s review of …

    • FDA Proposes Updates to the Special 510(k) ProgramOctober 3rd, 2018

      On September 28, 2018 FDA issued a new draft guidance document: The Special 510(k) Program (“draft guidance”). The draft guidance was followed by the announcement on October 1, 2018 of a Special 510(k) Pilot Program. The Special 510(k) program was established in 1998 to create a …

    • Draft Guidance Explains how Uncertainty should be Handled in Device Premarket SubmissionsOctober 2nd, 2018

      It is common for uncertainty to arise during the premarket review of novel medical devices. How CDRH has handled that uncertainty in the context of its benefit-risk assessment has generally been somewhat of a black box.  While FDA has issued numerous benefit-risk guidances, the Agency …

    • FDA Issues Final Rule on Voluntary Malfunction Summary Reporting Program for Device ManufacturersSeptember 25th, 2018

      FDA recently issued its final rule for the Voluntary Malfunction Summary Program, which permits manufacturers to report certain device malfunctions for low-risk products in summary form on a quarterly basis, as an alternative to the Medical Device Reporting (MDR) requirements set forth in section 519 …

    • Will a “Quik” 510(k) be a Quick 510(k)?September 14th, 2018

      On September 6, 2018, FDA launched the Quality in 510(k) Review Program Pilot (“Quik”). With the name “Quik,” it has a lot to live up to.  The goal of the program is to simplify the 510(k) process by providing an alternate method of preparing a …