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  • Medical Devices

    • Will a “Quik” 510(k) be a Quick 510(k)?September 14th, 2018

      On September 6, 2018, FDA launched the Quality in 510(k) Review Program Pilot (“Quik”). With the name “Quik,” it has a lot to live up to.  The goal of the program is to simplify the 510(k) process by providing an alternate method of preparing a …

    • FDA Seeks Comments on Proposed List of Medical Device Accessories Suitable for Class I ClassificationAugust 31st, 2018

      Comment one, comment all! As part of FDA’s ongoing effort to clarify the classification for medical device accessories (see our previous posts here, here, and here), on August 17, 2018, FDA issued a notification  requesting comments on a proposed list of accessories that FDA believes …

    • Draft Guidance Falls Short on Providing Clarity for Companies Denied Certificates to Foreign GovernmentAugust 27th, 2018

      One of the most painful consequences of a bad inspection at a U.S. facility is FDA’s resulting refusal to issue certificates to foreign governments (CFGs) until the issues are resolved. CFGs are quite often a requirement to renew licenses and permits to sell in various …

    • FDA’s IVD TA: It’s Not Just Technical AssistanceAugust 14th, 2018

      Since 1992, the Food and Drug Administration’s (FDA’s) efforts to regulate laboratory developed tests (LDTs) have been one of the most controversial device regulatory topics.  We have written about this topic multiple times (see our list at the end of this post). The focus of many …

    • Blind Voting and PMA Advisory Panels: “Do Great Minds Think Alike?”July 2nd, 2018

      By Jeffrey N. Gibbs and David A. Gibbs* – FDA’s premarket approval (PMA) advisory panels are high visibility events. Both FDA and companies invest heavily in preparing for these meetings. Thus, when the rules governing PMA panel meetings change, it should be big news. Yet, when FDA …

    • Potential Major Changes in Updated Draft Pre-Sub GuidanceJune 24th, 2018

      By far one of CDRH’s greatest recent successes has been the Pre-Submission program. In our experience, more companies have been engaging early and often with the Agency to discuss product-related regulatory issues and questions. Under the Food and Drug Administration Reauthorization Act and the MDUFA …

    • FDA Finalizes 510(k) Exemptions for Certain Class II DevicesJune 12th, 2018

      On June 5, 2018, FDA published a notice in the federal register finalizing the 510(k) exemption for several devices. The proposed list for 510(k) exemption was published last November and included two new devices that had been granted marketing authorization through the de novo process …

    • CDRH Issues Draft Guidance Regarding Test Reports for Nonclinical Bench Studies in Premarket SubmissionsJune 7th, 2018

      On May 31, 2018, CDRH issued the draft guidance, “Recommended Content and Format of Complete Test Reports for Non-Clinical Bench Performance Testing in Premarket Submissions.” The draft guidance is intended to provide an outline of the type of information to be included in non-clinical bench …

    • A Future Regulatory Paradigm with Potential Broader ImplicationsMay 29th, 2018

      Since our last post on Digital Health, FDA has continued their public campaign to raise awareness and seek input on the Software Precertification (Pre-Cert) Program. This blog post covers topics that don’t affect only software companies. While the focus is on software, the potential implications …

    • FDA Issues Report on Medical Device Servicing, Declining to Impose New Regulatory Requirements For NowMay 18th, 2018

      On May 15, FDA issued a Report on the Quality, Safety, and Effectiveness of Servicing of Medical Devices in which FDA concludes that it will not impose additional or different regulatory requirements on the third-party servicers of medical devices at this time. FDA issued this Report …

    • FDA Announces Proposal to Amend Product Jurisdiction Regulation – A Bit Better But Not Good EnoughMay 17th, 2018

      On May 15th, FDA published in the Federal Register a proposal to amend the product jurisdiction regulation (21 C.F.R. Part 3). This proposal seeks to update, clarify, and streamline the product classification and designation process.  However, the proposal fails to address some significant flaws in …

    • Multiple Function Device Products – FDA Clarifies Its ApproachMay 8th, 2018

      On April 27, 2018 FDA released a draft guidance describing the regulatory approach and policy for multiple function device products. The draft guidance, Multiple Function Device Products: Policy and Considerations, is available here and has been issued in response to the 21st Century Cures Act section …

    • A Tale of Two Guidances: FDA Issues Final Next Generation Sequencing GuidancesApril 29th, 2018

      On April 13, 2018, FDA issued the final guidance documents “Considerations for Design, Development, and Analytical Validation of Next Generation Sequencing (NGS) – Based In Vitro Diagnostics (IVDs) Intended to Aid in the Diagnosis of Suspected Germline Diseases” (hereinafter the NGS Guidance, available here) and …

    • FDA’s Proposed Expansion of the Abbreviated 510(k) ProgramApril 26th, 2018

      Earlier this month, FDA issued a draft guidance: Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria. This draft guidance would expand use of the Abbreviated 510(k) pathway as follows: “The intent of the guidance is to describe an optional pathway for …

    • FDA Issues Guidance Regarding Obtaining Risk Determinations for Investigational IVDs in Oncology TrialsApril 24th, 2018

      On April 12, 2018, the three FDA Centers jointly issued the draft guidance, “Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination” (draft available here). The draft guidance outlines a process for obtaining FDA’s feedback regarding whether an investigational IVD …