On Wednesday, the FDA issued a new draft guidance document with the goal of assisting medical device companies in navigating their way through the advisory committee review process. The guidance includes information such as potential medical device advisory committee review topics, a review timeline, a discussion around the briefing materials for each meeting (i.e. the “panel pack”), panel voting and presentations for both the sponsor and the Agency.
The guidance does not cover meetings with MDAC’s Dispute Resolution Panel (DRP) or other non-MDAC advisory panels related to medical devices, including the Device Good Manufacturing Practice Advisory Committee, the National Mammography Quality Assurance Advisory Committee or the Technical Electronic Product Radiation Safety Standards Committee.The new draft guidance document, Procedures for Meetings of the Medical Devices Advisory Committee, pertains to the to 17 of the 18 Medical Devices Advisory Committee (MDAC) panels overseen by FDA’s Center for Devices and Radiological Health (CDRH), the FDA center in charge of regulating medical devices.
Advisory committee reviews are open meetings called by the FDA to discuss or review a particular drug product or medical device. Most often, the circumstances around an advisory committee meeting may involve the need to gather advice on a premarket submission, which may include topics such as novel technology expected to have a significant impact on clinical practice, study results that provide significant uncertainty as to whether the probable benefits of the device outweigh its probable risks and data quality or data integrity issues identified (e.g., substantial amounts of missing data, large number of protocol deviations, data integrity concerns).
Advisory committees are comprised of individuals external to the Agency (i.e. non-FDA) who are experts in a specific field or topic.These panels consist of both voting and non-voting members. Advice dispensed by these panels is non-binding (i.e. the Agency is not obligated to follow the advice of its panels), though their recommendations are often followed by FDA regulators.
Some Useful Takeaways
- Expect to be asked by the Agency for an advisory committee panel review if your device involves novel technology, there is lingering uncertainty as to whether your product’s benefits outweigh its risks or if there are questions around the quality of your data
- Expect to participate in an advisory committee review if there are serious regulatory issues around your product such as classification/reclassification
- Keep posted to results of advisory committee reviews, which can also include advice for industry such as how to conduct a clinical trial for a particular device type
- Sponsors are generally provided 60 minutes (and up to 90 minutes under certain circumstances) for their presentation
- Depending on the complexity of the regulatory issues being discussed during a meeting, CDRH may choose to conduct pre-meeting training for their panel members
- Every advisory committee meeting includes an open public hearing session, during which interested persons may present relevant information or views orally or in writing
Proposed Timeline According to Draft Guidance
- Approximately 42 days before the panel meeting, CDRH expects the sponsor to submit two versions of its proposed sections of the Panel Pack to CDRH (a complete unredacted version and a redacted version for FDA Freedom of Information (FOI) review)
- Between 42 and 22 days before the panel meeting, the sponsor, along with CDRH, “should exchange and review for factual errors the information proposed by each party to be included in the Panel Pack”
- Approximately 21 days before the panel meeting, the sponsor should receive a final unredacted Panel Pack from CDRH
- Approximately 5 days before the panel meeting, the sponsor should exchange their presentation slides with CDRH
- Approximately 2 days before the panel meeting, CDRH should post the briefing materials to the public that pertain to the meeting
Comments on the guidance will be accepted by FDA for the next 60 days.
ISS has over a decade of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComs per year than even the largest pharmaceutical companies. We have experience across several therapeutic categories, a proven, long-standing relationship with the FDA, as well as the scientific and business acumen to navigate the complicated waters of the FDA Advisory Committee meeting process. For more information on how ISS can help you prepare for your next meeting, contact email@example.com.
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