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  • Medical Devices

    • 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  We previously blogged on the draft version (“Draft Guidance”) here.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 …

    • Upcoming Conference on Digital Health Regulatory IssuesApril 1st, 2019

      The Food and Drug Law Institute (FDLI) is holding a conference devoted to digital health regulatory issues:  Medical Devices: FDA Regulation in the Era of Technology and Innovation. Hyman, Phelps & McNamara’s Jeffrey K. Shapiro is the Chair.  The conference will be held in South …

    • To Ask, or Not to Ask, That is the Question: FDA Guidance on Nonbinding Feedback After Certain Inspections of Device EstablishmentsMarch 17th, 2019

      FDA recently issued a draft guidance document, Nonbinding Feedback After Certain FDA Inspections of Device Establishments, which outlines the process for obtaining FDA feedback on proposed remedial actions in response to observations issued on a Form 483, the Agency’s Inspectional Observations Form, following an inspection. Background Section …

    • Emerging Technology: Implanted Brain Computer Interface Devices for Patients with Paralysis or AmputationMarch 13th, 2019

      An Implanted Brain Computer Interface (BCI) device may sound like something out of science fiction, but FDA apparently believes these devices are on their way to becoming a reality.  FDA recently released a draft guidance document that provides recommendations on how to gain approval to …

    • ACI’s 33rd FDA Boot Camp – New York City EditionMarch 8th, 2019

      The American Conference Institute’s (“ACI’s”) popular “FDA Boot Camp” – now in its 33rd iteration – is scheduled to take place from March 25-27, 2019, at the Park Lane Hotel in New York, NY. The conference is billed as the premier event to provide folks …

    • The Final Safety and Performance Based Pathway Guidance Is OutFebruary 21st, 2019

      You might remember our prior post on FDA’s proposed expansion of the Abbreviated 510(k) Program. FDA recently issued a final guidance on this program with a brand-new name: Safety and Performance Based Pathway. Other than the new moniker, the final guidance does little to change …

    • Balancing Benefit and Risk in Medical Device RegulationFebruary 20th, 2019

      Medical devices provide important diagnostic and treatment benefits to patients. Every day, thousands of patients are the beneficiaries of amazing technology that often did not exist even 10 years ago, and certainly not 50 years ago. At the same time, these medical devices can pose risks …

    • FDA Issues Final Guidance on Least Burdensome ProvisionsFebruary 13th, 2019

      On February 5, 2019, FDA issued the guidance document The Least Burdensome Provisions: Concept and Principles (Final Guidance).  This version supersedes the prior version in place since October 2002.  FDA published a draft of the guidance (Draft Guidance) in December 2017, which we blogged on …

    • And the Nominees Are…. FDA Law Blog’s Top 10 Device Posts of 2018February 11th, 2019

      The recent government shutdown gave us some time to reflect on 2018, a year that was full of device-related posts.  Inspired by the recent Academy Awards nominations, we are now listing our Top Ten Device Posts of 2018.  Some are blockbusters, and others indie stories, …

    • New Efforts to Expand Access to Laboratory Tests in MarylandFebruary 6th, 2019

      Readers who work with laboratory tests are likely aware that such tests can be subject to regulation by FDA, CMS, and individual states. A few state laws, particularly those in Maryland, New York, New Jersey, and Rhode Island, currently constrain how some laboratory tests are …