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  • Medical Devices

    • 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 …

    • FDORA Enacted; HP&M Issues Detailed Summary and AnalysisJanuary 23rd, 2023

      On December 29, 2022, the President signed into law the Food and Drug Omnibus Reform Act of 2022 (“FDORA”) as part of the Consolidated Appropriations Act, 2023, Pub. L. No. 117-328 (2022).  FDORA primarily amends the Federal Food, Drug, and Cosmetic Act and the Public …

    • FDA and Health Canada eSTAR Pilot is Open and Accepting Participant RequestsJanuary 17th, 2023

      A joint eSTAR pilot (which we previewed in November) between FDA and Health Canada has now been launched. This pilot program will test the use of a single eSTAR application submitted to both regulatory bodies. For those unfamiliar or needing a refresher, eSTAR is an interactive …

    • As the Calendar Turns, Cybersecurity Remains Key Focus of Digital Health EnforcementJanuary 6th, 2023

      As we turn into the New Year, we offer a few items of interest in digital and telehealth regulation, enforcement, and compliance that may provide some helpful guideposts for stakeholders. In 2022, the chief regulating entities—FDA, FTC, and DOJ—all continued to forge policies to help bridge …

    • ACI’s 40th FDA Boot Camp – March 22-23, 2023 (Virtual)January 3rd, 2023

      Hosted by American Conference Institute, the FDA Boot Camp returns for its 40th iteration with the continued intent of providing an essential working knowledge of core FDA concepts, and real-world examples that will help you to excel in your everyday practices. This year’s conference co-chairs include …

    • Doctoring the Law: Congress May Let FDA Regulate the Practice of MedicineDecember 22nd, 2022

      Back in June, when Congress was negotiating the User Fee Acts, FDA asked Congress to add in some provisions reversing several lawsuits that it had just lost.  Ultimately, FDA lost that fight, and a slimmed down version of the FDA Safety and Landmark Advancements (“FDASLA”) …

    • FDA’s Recent Update to the Digital Health Policy NavigatorDecember 21st, 2022

      In our previous blog post, we provided a flowchart for the Digital Health Policy Navigator’s process so that our blog readers can quickly review the seven steps in determining whether their product’s software functions may be potentially the focus of FDA oversight. Two days after …

    • FDA Publishes Draft Guidance on Voluntary Malfunction Summary Reporting Program for Medical DevicesDecember 18th, 2022

      On December 9, 2022, FDA issued a draft guidance document on the Voluntary Malfunction Summary Reporting (VMSR) Program for medical devices. Generally, FDA’s MDR regulations require device manufacturers to submit Medical Device Reports (MDRs) for individual reportable malfunctions within 30 calendar days of the manufacturer becoming …

    • Remote Patient Testing Faces a Cloudy Future under VALIDDecember 14th, 2022

      It is widely expected that the fate of the VALID Act – and therefore the world of diagnostic regulation – will be determined in the next two weeks (see our previous post here).  While the potential mitigating impact of the “grandfathering” clause on laboratories currently …

    • Draft LASIK Guidance: Why Did FDA Issue New Labeling Recommendations for Products that Already Have PMA Approved Labeling?December 13th, 2022

      Last summer, FDA published a draft guidance, Laser-Assisted In Situ Keratomileusis (LASIK) Lasers – Patient Labeling Recommendations (July 29, 2022) setting forth a proposal for new recommended patient‑directed labeling.  It is focused on excimer lasers with premarket application (PMA) approval for LASIK  in product code …

    • Is my Software a Medical Device? Use the Digital Health Policy NavigatorDecember 12th, 2022

      With the explosion of health‑related software, many software developers are generating products with functionality that is subject to regulation by the Food and Drug Administration (FDA).  If you are a manufacturer of implants that go into the human body for the treatment of disease, it’s …

    • 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 …

    • Discounts Available! Submit a Small Business Certification Request Today for a Reduced Medical Device User FeeNovember 15th, 2022

      In our last blog post, we advised medical device companies to consider applying to FDA’s Small Business Program to help with the noticeably higher user fees for FY2023. In this blog post, we provide a primer on user fees and the Small Business Program. User Fees User …

    • FUFRA Enacted; HP&M Issues Detailed Summary and AnalysisNovember 9th, 2022

      On September 30, 2022, President Biden signed into law the Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023, Division F of which is titled the “FDA User Fee Reauthorization Act of 2022” (“FUFRA”).   In addition to reauthorizing for an additional five fiscal years—Fiscal Years 2023-2027—several …

    • MedTech Conference DownloadNovember 9th, 2022

      At the latest MedTech conference held in Boston, MA from October 24-26, we heard from FDA officials and industry representatives on a range of topics. Below, we provide a snapshot of the three-day event: Update on the International Medical Device Regulators Forum (IMDRF) The IMDRF conference was …