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    • The Rise of eSTAR for Medical Device De Novo SubmissionsOctober 24th, 2023

      As of October 1, 2023, all 510(k) submissions, unless exempted, must be submitted to FDA using the electronic Submission Template And Resource (eSTAR).  The same template can also be used for De Novo submissions.  Currently, eSTAR is voluntary for medical device De Novo submissions, but …

    • When Should a 510(k) Include Clinical Data?October 18th, 2023

      Although it seems not widely known outside of the medical device industry, FDA can require sponsors to include clinical data as part of a 510(k) submission.  Such data may be needed to demonstrate substantial equivalence to a previously-marketed predicate device or, less frequently, to show …

    • New Breakthrough Devices Program Guidance: Expanding Opportunities for Medical Product InnovationsOctober 17th, 2023

      On September 15, 2023, FDA released a final guidance document titled “Breakthrough Devices Program.”  Compared to the previous version, the new guidance document highlights that the Breakthrough Devices Program may also be applicable to certain devices that benefit populations impacted by health and/or healthcare disparities …

    • AI/ML-enabled Medical Devices Have Everyone’s Attention, Including FDA’sOctober 16th, 2023

      The Wall Street Journal (WSJ) recently published a series of articles as part of its special report “What’s Ahead for Artificial Intelligence.” Three of these articles focus on medical applications of Artificial Intelligence and Machine Learning (AI/ML) and explore FDA’s role in regulating such products. The …

    • FDA’s New Draft Guidance on 510(k) Implant Devices: What You Need to KnowOctober 11th, 2023

      As we recently blogged, FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program.  One of these documents focuses on “Evidentiary Expectations for 510(k) Implant Devices.”  Implant devices are used in a range of settings such as …

    • Proposed LDT Rule Raises Many Questions but Provides Few AnswersOctober 6th, 2023

      As we reported last week, FDA has issued a 26 page, single spaced, tiny-font Proposed Rule of Laboratory Developed Tests (LDTs).  There is much to unpack, and we intend to do so in a series of blog posts. In this post, we focus on the …

    • We Have an LDT Proposed Rule!September 29th, 2023

      It’s the moment we’ve all been waiting for, dreading, anticipating . . . . Today, FDA released a copy of a proposed rule to regulate laboratory-developed tests (LDTs), which is scheduled to be published in the Federal Register on October 3rd.  The proposed rule has a …

    • Logistics Unwrapped: A Roadmap to Successful FDA Meetings in In-Person and Hybrid FormatsSeptember 18th, 2023

      Over the last three and a half years, meetings with FDA were conducted virtually.  During this time, CDRH moved from Webex to Zoom and gained experience with the virtual platform.  Now, in addition to engaging with FDA via Zoom, medical device sponsors can once again …

    • 510(k) Modernization 2023September 12th, 2023

      On September 6, 2023, FDA announced its latest efforts to modernize the 510(k) process, outlining FDA’s latest improvements to strengthen the 510(k) Program and announcing release of three draft guidance documents.  This announcement addresses one of the commitments in FDA’s Medical Device Safety Action Plan: …

    • Wearables, Sensors, and Apps Part 2 – Development and Qualification of Digital Health Technologies in Drug and Biological Product DevelopmentAugust 29th, 2023

      Following up on our first post discussing Digital Health Technologies (DHTs) (here), this post will focus on development and qualification of DHTs for use in clinical trials for drug development.  Earlier this year, FDA hosted a public meeting, Understanding Priorities for the Use of Digital …

    • Wearables, Sensors, and Apps Part 1 – Updates on FDA’s PDUFA VII Goals for the Use of Digital Health Technologies in Drug and Biological Product DevelopmentAugust 24th, 2023

      As part of FDA’s Prescription Drug User Fee Act (PDUFA) VII goals published in PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2023 through 2027 (PDUFA Goal Letter), which we blogged about here, FDA included a goal for enhancing use of digital health technologies (DHT) …

    • 2024 Fall CDRH ELP Proposal Submission Period is Now Open Through September 5, 2023August 7th, 2023

      The Center for Devices and Radiological Health (CDRH) offers learning opportunities for new and experienced CDRH staff through the Experiential Learning Program (ELP). Through ELP, CDRH staff visit sites that provide formal training and enhance understanding on topics such as how products are developed and …

    • Mastering Responses to FDA 510(k) AI Letters: A Strategic ApproachJuly 10th, 2023

      It takes a significant amount of time, cost, and effort to prepare a premarket notification 510(k) submission.  But that is only the beginning.  After a firm submits a 510(k) to FDA, FDA will request still more information after a first-pass review.  According to the 2nd …

    • Finalizing the Quality Management System Regulation – A High Priority for End of 2023July 6th, 2023

      Earlier this year, neither the Quality System Regulation (QSR) nor the Quality Management System Regulation (QMSR) were referenced in the semiannual regulatory agenda. We now see that the proposed rule to “harmonize and modernize” the QSR with ISO13485:2016, creating the new QMSR, is on the Spring …

    • Is ASCA worth it? FDA’s Accreditation Scheme for Conformity AssessmentJune 28th, 2023

      The Center for Devices and Radiological Health’s (CDRH) Standards and Conformity Assessment Program (S-CAP) encourages medical device sponsors to use FDA-recognized voluntary consensus standards in their product submissions.  Use of voluntary consensus standards can reduce regulatory burden, streamline conformity assessment, harmonize requirements globally, and enhance …