On April 1st, the FDA issued a draft guidance that provides more comprehensive information for industry and CDRH on the processes associated with panel device meetings. The new draft guidance document, Procedures for Meetings of the Medical Devices Advisory Committee, pertains to the to 17 of the 18 Medical Devices Advisory Committee (MDAC) panels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.
Once finalized, the updated guidelines will replace a 2000 CDRH guidance document on the panel process and a 1991 blue book memo. Thus, the guideline clarifies the circumstances in which the CDRH consults with a device advisory panel, the conduct of panel meetings and the expected timelines to prepare for a panel meeting.
The agency refers to its advisory panels when seeking advice on premarket submission, or on regulatory issues including classification/reclassification or other general issues. The guidance also states that advisory panels will not be used exclusively to support PMA decisions, but rather are to be considered in cases where sponsors are seeking 510(k)s, de novo classifications and humanitarian device exemptions.
The draft guidance does make clear that it can take one-to-two months of staff and industry time to consider and review “panel packs” of information that include panel briefing materials.
FDA sets out a detailed timeline for interactions between the sponsor and CDRH leading up to the panel meeting. The FDA recommends the product sponsor to:
- Relay two versions of its proposed “panel pack” within 42 days; one complete version for FDA and a redacted version for FDA Freedom of Information review
- Send to the agency the final version of the “panel pack” by 14 to 21 days
- Ship the draft slides intended for presentation within five days of the meeting (and CDRH must also send the sponsor its draft slides within five days)
At every step of the way the CDRH is involved with these submissions making judgments on relevance and completeness and corresponding back with the sponsor and the panel. Two days prior to the meeting, the CDRH will post to the FDA website the publically available meeting materials. Come the day of the meeting, both the CDRH and the sponsor will be given 60 minutes, or up to 90 minutes each, in special circumstances, to present their case. The intention is, after going through this process, that both parties will be well-prepared to be given full consideration before a vote.
Sponsors will need to understand the changes in the guidance so they can prepare for potential panel questions before PMA submission and engage early and often with FDA throughout the device development process. This new guidance makes it clear that it is never too early to begin panel preparation!
Let us know your thoughts on the new draft guidance.