FDA
3rd April 2015

FDA Issues New Draft Guidance for Medical Device Advisory Committee Reviews

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.

FDA Issues New Draft Guidance for Medical Device Advisory Committee Reviews

On Wednesday, the FDA issued a new draft guidance document with the goal of assisting medical device companies in navigating their way through the advisory committee review process.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Quality Assurance Advisory Committee or the Technical Electronic Product Radiation Safety Standards Committee.The new draft guidance document, Procedures for Meetings of the Medical Devices Advisory Committee, pertains to the to 17 of the 18 Medical Devices Advisory Committee (MDAC) panels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 info@innovativescience.net.

Do you have an upcoming Advisory Committee Meeting?

White Oak Gude

Recent Related Articles

Best Tips for Medical Device Manufacturers to Write a Compelling Substantial Equivalence Section for their FDA 510k Submission
01 July 2020
Best Tips for Medical Device Manufacturers to Write a Compelling Substantial Equivalence Section for their FDA 510k Submission

Over the past few years, the number of ex-US manufacturers submitting a Class II exempt 510k device registration has increased substantially. For companies with medical devices that are approved and successful in a foreign market, the logical next step is to introduce their product into the US, which has one of the most lucrative healthcare markets in the world. Read more

Evolving FDA Thinking on Advisory Committee Meetings Related to Foods, Drugs, and Devices
25 June 2020
Evolving FDA Thinking on Advisory Committee Meetings Related to Foods, Drugs, and Devices

FDA advisory committee meetings are important regulatory events for many manufacturers on the path to marketing approval. These meetings can quite literally result in the approval or rejection of a product based on the panel’s vote. Read more

NDA vs. OTC Monograph: Which Pathway is Right for You?
22 June 2020
NDA vs. OTC Monograph: Which Pathway is Right for You?

One of the main challenges our clients face is determining which regulatory pathway is best for their products. For example, what if an OTC product has a Monograph active ingredient but that ingredient is present at a different amount than the permitted amount? Or what if the label claims a novel indication not specified in a Monograph? If you are debating pursuit of either regulatory pathway for your OTC drug, it is critical to consider cost, timeline, and label claims to ensure your products has a unique stance in today’s market. Read more

4 Problems Importing Rapid Antibody Tests for Coronavirus
19 June 2020
4 Problems Importing Rapid Antibody Tests for Coronavirus

US distributors and agents trying to import rapid antibody tests for coronavirus face a number of obstacles. The good news is that FDA has opened up the Emergency Use Authorization (EUA) program to include SARS-CoV-2 (the virus) and COVID-19 (the disease), expediting time to market. Read more

Let’s work together

The journey to scientific and commercial success is often complex and always critical, if you are looking for an expert partner to help steer you to confident solutions, contact us today

Contact us