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  • Medical Devices

    • CDRH Issues Final Guidance Regarding Interoperable Medical DevicesSeptember 24th, 2017

      On September 6, 2017, FDA issued the final guidance “Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices.” The final guidance can be found here. The document provides guidance regarding interoperable devices, which it defines as devices “that have the ability to exchange and …

    • FDA to Hold Meeting on Home Collection of Pap Smears: Possible Broader Implications?September 21st, 2017

      The reduction in the rate of cervical cancer is one of the great success stories in public health.  The introduction of the Pap smear and human papillomavirus (HPV) testing has led to a significant reduction in the rate of cervical cancer.  However, there are still …

    • Webinar: FDA Medical Device Submissions – You’ve Got Legal Questions – We Have the ExpertSeptember 19th, 2017

      Hyman, Phelps & McNamara, P.C.'s Jeffrey N. Gibbs has teamed up with MassMEDIC and Right Submission to bring you a free webinar, titled "FDA Medical Device Submissions – You’ve Got Legal Questions – We Have the Expert," that focuses on legal questions you might have relative to FDA product …

    • FDARA Enacted; HP&M Issues Detailed Summary and AnalysisSeptember 7th, 2017

      On August 18, 2017, President Trump signed into law the Food and Drug Administration Reauthorization Act of 2017 (“FDARA”).  In addition to reauthorizing and amending several drug and medical device provisions that were scheduled to sunset, FDARA also makes several changes to the law concerning …

    • Medical Device “Fraud on the FDA” Theory Might Be Viable in Minnesota, if Properly PledSeptember 6th, 2017

      Since the Supreme Court issued its False Claims Act (“FCA”) ruling in Universal Health Services, Inc. v. U.S. ex rel. Escobar, 136 S. Ct. 1989 (2016) courts have grappled with Escobar’s concept of FCA “materiality.” Materiality was described by the Supreme Court as a “rigorous” …

    • CDRH Schedules Inaugural Meeting of Patient Engagement Advisory CommitteeAugust 7th, 2017

      FDA’s Center for Devices and Radiological Health (CDRH) recently announced in the Federal Register and the FDA Voice blog that it has scheduled the first-ever meeting of the Patient Engagement Advisory Committee (PEAC), which will provide recommendations to FDA regarding the regulation of medical devices …

    • When It Comes to Software As A Medical Device (SAMD), FDA Acknowledges that New Technology No Longer Fits The Old Regulatory Paradigm August 7th, 2017

      When you think about it, FDA’s general regulatory paradigm for regulating medical devices has enjoyed a tremendous run. The overarching statutory and regulatory foundation was started in 1976 and largely in place in its current form by 1997. (Think 510(k)/de novo/IDE/PMA requirements for the premarket …

    • FDA Finalizes List of Class II Devices for 510(k) ExemptionJuly 20th, 2017

      On July 11, 2017, in the Federal Register, FDA published the finalized list of Class II devices that are now exempt from the 510(k) requirements. This list is identical in substance to the proposed list published on March 14, 2017 (see our prior post here). …

    • ACI’s 5th Annual FDA Boot Camp: Devices EditionJuly 16th, 2017

      The American Conference Institute’s (“ACI’s”) 5th annual “FDA Boot Camp: Devices Edition” conference is less than two weeks away! The conference will take place from July 26-28, 2017 in Chicago, Illinois.  Jonette Foy, Ph.D., Associate Director for Policy (acting), CDRH, FDA will be presenting a keynote …

    • Is The 510(k) Process As Worthless As The Federal Courts Seem to Believe?July 11th, 2017

      Does the Food and Drug Administration’s review of medical devices in the 510(k) program involve a substantial review of safety and effectiveness? FDA says it does (p. 44). Device makers and those of us who practice in this area know how burdensome and extensive this …

    • User Fee Reauthorization Moves One Step Closer to Reality with House Committee PassageJune 8th, 2017

      On June 8, 2017, after a long mark-up session, the House Energy and Commerce Committee unanimously (54-0) passed H.R. 2430, the FDA Reauthorization Act of 2017 (“FDARA”). The Senate version of the bill, S. 934, passed out of the Health, Education, Labor, and Pensions Committee …

    • For the Love of Money: The Trump Administration’s Fiscal Year 2018 FDA Budget PlanMay 23rd, 2017

      Cue up “For The Love of Money” by The O’Jays (and theme song of The Apprentice) . . . The Trump Administration’s Fiscal Year 2018 Budget Proposal is out! On May 23, 2017, The White House Office of Management and Budget released President Trump’s Fiscal Year …

    • FDA, Under New Leadership, Seeks More Comments on Rules Affecting Off-Label CommunicationsMay 19th, 2017

      Dr. Scott Gottlieb was sworn in as FDA’s 23rd Commissioner on May 11, 2017. There has been a lot of speculation about what policies he will prioritize for the Agency during his tenure.  A review of his background shows he has been an advocate for …

    • LDTs: The Saga ContinuesMay 14th, 2017

      Over its ten years the FDA Law Blog has posted numerous stories about FDA's regulation of laboratory developed tests (LDTs) (see, e.g., here, here, and here)  Yet, the story of FDA's efforts to regulate LDTs goes back even further than the FDA Law Blog, to …

    • ACI’s 5th Annual FDA Boot Camp: Devices EditionMay 12th, 2017

      The American Conference Institute’s (“ACI’s”) 5th annual “FDA Boot Camp: Devices Edition” conference is coming up fast! The conference will take place from July 26-28, 2017 in Chicago, Illinois. ACI’s FDA Boot Camp: Devices Edition delivers in-depth coverage of FDA regulatory law to professionals who work …