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    • FDA Finalizes Updates to the Special 510(k) ProgramSeptember 19th, 2019

      On September 13, 2019 FDA issued a final guidance document The Special 510(k) Program (“Guidance”).  We blogged about the prior draft guidance here.  This Guidance, along with The Abbreviated 510(k) Program, supersedes the 1998 guidance document The New 510(k) Paradigm – Alternate Approaches to Demonstrating …

    • CDRH Issues Final Guidance on De Novo Submission Acceptance ReviewSeptember 13th, 2019

      On September 9, 2019, FDA issued a final guidance, Acceptance Review for De Novo Classification Requests.  The guidance is meant to provide clarity on the Agency’s expectations for information to be submitted in a De Novo request and to ensure predictability and consistency for sponsors.  …

    • Deference to Agency DeferenceAugust 27th, 2019

      Companies challenging FDA in court typically face a steep uphill battle given the long-standing doctrine known as Auer deference, which (in simplified terms) requires courts to defer to FDA’s interpretation of its own regulations if they are ambiguous.  The recent Supreme Court ruling in Kisor …

    • FDA Law Alert: Issue #2August 7th, 2019

      Hyman, Phelps & McNamara, P.C. is pleased to publish this second issue of the FDA Law Alert, a newsletter highlighting key postings from our nationally acclaimed FDA Law Blog.  Please subscribe to the FDA Law Blog to receive contemporaneous posts on government regulatory and enforcement …

    • FDA Issues Final Guidance on Postmarketing Safety Reporting for Combination ProductsAugust 5th, 2019

      FDA recently finalized the guidance document, Postmarketing Safety Reporting for Combination Products (“PMSR Guidance”).  The PMSR Guidance addresses compliance with the final rule on postmarketing safety reporting (PMSR) requirements, 21 C.F.R. Part 4, Subpart B (“PMSR final rule”), for combination products.  This is a complicated …

    • PMA Panel Votes: More Than Meets the EyeJuly 11th, 2019

      FDA advisory panel meetings to review pre-market applications (PMAs) are high-stakes events.  While FDA is not bound by the vote of the advisory panel, it has been long-accepted that the agency typically follows the recommendation of the panel. Which got us thinking:  are conventional wisdom and …

    • Cybersecurity Fears Lead to Insulin Pump RecallJuly 3rd, 2019

      On June 27, Medtronic announced that it was recalling certain MiniMed insulin pumps due to “potential security vulnerabilities.”  On the same day, FDA issued a Safety Communication and the Department of Homeland Security issued a Cybersecurity Infrastructure Security Advisory about the same issue. FDA’s Safety Communication …

    • Device Manufacturer’s Criminal and Civil Penalties Deserve Closer AttentionJuly 2nd, 2019

      Today’s blog post illustrates how a company’s problems can escalate rapidly from an administrative warning letter to the full weight of the criminal system.  The unfortunate subject is ACell, a manufacturer of medical devices derived from porcine urinary bladder material.  ACell received a Warning Letter …

    • SCOTUS Makes it Easier for Government to Withhold Commercial or Financial InformationJune 26th, 2019

      In a 6-3 decision, the U.S. Supreme Court reversed and remanded the lower courts’ decision to publicly disclose commercial information that previously had been submitted to the government.  Given that FDA-regulated entities often submit to FDA commercial or financial information that those entities regard as …

    • FDA Updates MDR Program in an Effort to Increase TransparencyJune 25th, 2019

      FDA recently announced new changes it is making to the Medical Device Reporting (MDR) program as part of its ongoing efforts to increase transparency on device performance, and detection of device-related safety concerns. FDA is formally discontinuing the Alternative Summary Reporting (ASR) Program, which permitted certain …

    • FDA’s Pre-Cert Program Enters its Testing PhaseMay 29th, 2019

      FDA’s Software Pre-Certification (Pre-Cert) Program is intended to create a new streamlined regulatory process for software as a medical device (SaMD) (see our earlier blog posts on the program here, here, here, and here).  In January of this year, FDA released version 1.0 of Developing …

    • FDA Finalizes Guidance on Non-Clinical Bench Performance Testing Information in Premarket SubmissionsMay 15th, 2019

      On April 26, 2019, CDRH released the final guidance, Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions (“Final Guidance”).  We previously blogged on the draft version (“Draft Guidance”) here.  Overall, the Final Guidance is much the same as the Draft …

    • Final Guidance on UDI Labeling for Convenience Kits Brings Additional ClarityMay 1st, 2019

      Last week FDA issued a final guidance, Unique Device Identification: Convenience Kits, which clarifies FDA’s interpretation of a convenience kit for purposes of UDI labeling requirements.  We previously blogged on the draft version here.   As our readers know, the unique device identification system regulations require …

    • Advertising Laboratory Tests: Change on the Way in MarylandApril 12th, 2019

      The 2019 Maryland Legislative Session closed on April 8th with an exciting development related to laboratory testing.  As we previously reported (see here), Maryland law currently prohibits directly or indirectly advertising or soliciting for medical laboratories.  Two bills were introduced earlier this year to address …

    • FDA Starts A Discussion About How To Regulate Artificial Intelligence / Machine Learning Software As A Medical DeviceApril 4th, 2019

      A cutting-edge aspect of digital health is software as a medical device (SaMD) that uses artificial intelligence and machine learning to improve its performance based on real world use and experience.  Until earlier this week, FDA has said very little about how to handle the …