Posted 31 March 2015
By Alexander Gaffney, RAC
For many medical device companies, a meeting with a US Food and Drug Administration (FDA) Advisory Committee is a high-profile, high-stress event. A successful meeting can assure regulators, patients and investors that a product is safe and effective, while an unsuccessful meeting can torpedo a product's chances at a timely approval.
Now FDA is out with a new guidance document which aims to help medical device companies navigate the confusing lead-up process to an advisory committee meeting a bit more easily.
The draft guidance document, Procedures for Meetings of the Medical Devices Advisory Committee, relates to the 17 Medical Devices Advisory Committee (MDAC) panels overseen by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 committees are comprised of outside (i.e. non-FDA) experts in a specific field or topic. Most panels have about nine experts, including non-voting members representing consumer and industry interests.
Advice dispensed by these panels is non-binding, though their recommendations are often followed by FDA regulators.
CDRH's draft guidance is focused on most, but not all, medical device advisory committees and panels.
For example, it does not cover meeting 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.
Even with those omissions, the guidance still covers a wide variety of meetings. For example, MDAC's panels dispense advice about specific products under review by regulators, specific regulatory issues of interest or concern to FDA and the reclassification of medical device types.
Most companies will deal with the first of those panel types—MDAC's review of an investigational product. Not all devices are overseen by panels. CDRH says it will typically ask a panel to review a device if it involves:
- novel technology expected to have a significant impact on clinical practice
- study results provide significant uncertainty as to whether the probable benefits of the device outweigh its probable risks
- significant study data quality or data integrity issues identified (e.g., substantial amounts of missing data, large number of protocol deviations, data integrity concerns)
While most devices meeting these requirements will be submitted as a premarket approval application (PMA), MDAC will also consider devices submitted through FDA's 510(k) premarket notification pathway, humanitarian device exemption (HDE) applications and requests for de novo classification.
In practice, most devices reviewed by MDAC tend to be PMAs, however.
What the Advisory Committee Panels Need, and When
Advisory committee panels may be experts, but they can only do their jobs effectively if they have time to review data related to the device or issue at hand. Accordingly, CDRH prepares what is known as a "panel pack" to each advisory committee member consisting of:
- FDA’s agenda for the advisory committee meeting
- FDA’s executive summary of the issue
- FDA’s questions for the panel to consider
- the device sponsor’s executive summary of the issue
- "appropriate sections" or excerpts from the device submission
- other relevant information, such as related literature
FDA's guidance also includes a timeline of activities taking place in advance of the advisory committee meeting.
Companies need to send a draft outline of their materials to FDA "approximately 55 business days before the panel meeting," FDA explains in its guidance. Forty-two days in advance of the panel meeting, the sponsor should submit two versions of its panel pack to FDA: one with redacted information suitable for viewing by the public, and an un-redacted version to be read by FDA's advisory committee panel members. FDA will then review this material for factual accuracy over the next 20 days.
Twenty-one days prior to the meeting, CDRH will send the panel pack to its advisory panel members. Five days prior to the meeting, CDRH and the sponsor will exchange drafts of the presentation slides they plan to present at the meeting. And two days prior to the meeting, FDA will post the redacted panel pack materials to its website.
The guidance also describes the voting procedures used by the panels, as well as the amount of time dedicated to each part of the public advisory committee meeting.
Comments on the guidance will be accepted by FDA for the next 60 days.
Procedures for Meetings of the Medical Devices Advisory Committee (FR)