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    • 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      On April 27, 2018 FDA released a draft guidance describing the regulatory approach and policy for multiple function device products. The draft guidance, Multiple Function Device Products: Policy and Considerations, is available here and has been issued in response to the 21st Century Cures Act section …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      Earlier this month, FDA issued a draft guidance: Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria. This draft guidance would expand use of the Abbreviated 510(k) pathway as follows: “The intent of the guidance is to describe an optional pathway for …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      On April 12, 2018, the three FDA Centers jointly issued the draft guidance, “Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination” (draft available here). The draft guidance outlines a process for obtaining FDA’s feedback regarding whether an investigational IVD …

    • New RTA Policy Has Implications for Combination ProductsApril 3rd, 2018

      On January 30, 2018, FDA issued revised guidance documents: Refuse to Accept Policy for 510(k)s and PMAs (here and here). These revised guidances may have gone unnoticed by many as there was no federal register notice announcing or discussing the revisions from the policy in …

    • Least Burdensome – The Third Time’s the Charm?March 28th, 2018

      In 1997, Congress directed FDA to use the “least burdensome” approach in reviewing device applications. This legislation resulted in little change in behavior.  In 2012, Congress enacted new legislation with the same outcome. In 21st Century Cures, Congress addressed the “least burdensome” approach for the third …

    • FDA Publishes Final Rule and Guidance on Acceptance of Clinical Data to Support Medical Device Applications and SubmissionsFebruary 23rd, 2018

      On February 21, FDA published a final rule amending its regulations on the acceptance of data from clinical investigations for medical devices (83 Fed. Reg. 7366). These amendments are designed to ensure the quality and integrity of clinical data and the protection of human subjects.  …

    • FDA Issues Draft Guidance for Preparing a Pre-Request for DesignationFebruary 22nd, 2018

      On February 15, FDA’s Office of Combination Products (OCP) announced the draft guidance, “How to Prepare a Pre-Request for Designation (Pre-RFD).” Don’t let the name fool you though.  Unlike the similarly named Pre-Submission, a Pre-RFD does not need to precede a formal RFD.  A Pre-RFD …

    • FDLI’s New Medical Device Requirements and Where Manufacturers Should Focus: MDUFA, FDARA, and 21st Century CuresFebruary 8th, 2018

      On Friday, February 9, 2018, from 2:00-3:30 PM ET, the Food and Drug Law Institute (“FDLI”) will be hosting a webinar, titled “New Medical Device Requirements and Where Manufacturers Should Focus:  MDUFA, FDARA, and 21st Century Cures.” Hyman, Phelps & McNamara, P.C.’s Jeffrey N. Gibbs …

    • CDRH Publishes Metrics for Third-Party 510(k) ReviewsFebruary 7th, 2018

      The third-party 510(k) review process was an emphasis in the most recent user fee negotiations and statutory changes under the FDA Reauthorization Act of 2017 (FDARA). This process has been criticized in the past for being restrictive, ineffective, and not beneficial for applicants.  On January …

    • Join Us in April to Learn More about Improving Regulatory Compliance While Minimizing Products Liability!February 5th, 2018

      The fact is, regulatory compliance has an impact on products liability.  Yet, the two are seldom considered together. We aim to change that with a special day and a half program (April 12th and 13th).  Our FDA regulatory firm has teamed up with a renowned medical …

    • FDA Issues UDI Guidance for Class I and Unclassified DevicesJanuary 30th, 2018

      The final Unique Device Identifier (UDI) Rule was published on September 24, 2013. The last phases of implementation related primarily to Class I and Unclassified devices.  Due to complex issues identified during implementation of the UDI Rule for Class II and III devices, FDA is …

    • Nothing Appealing in Proposed Device Appeal Regulations: They are Identical to Existing GuidanceJanuary 26th, 2018

      The title of this blog post should tell you everything you need to know about the proposed appeal regulations announced last week by CDRH (found here). On January 17, CDRH proposed regulations specific to the device appeal process for both 517A decisions as well as …

    • CDRH Issues Revised Replacement Reagent PolicyJanuary 25th, 2018

      A week before Christmas, CDRH issued a revised draft of the Replacement Reagent policy. When finalized, the revised draft guidance will replace the 2003 final guidance. According to FDA, the revised guidance “is intended to update and provide clarity on” the existing policy. FDA has …