The FDA has released a draft guidance that will help medical device developers navigate the process of specialized medical device advisory committee (MDAC) panels. The agency hopes the document will assist industry and regulators understand the role of the panels in handling issues such as premarket submissions and regulatory issues.
According to the guidance, the Center for Devices and Radiological Health (CDRH) consults with 17 panels with different areas of expertise and authorization. Members of each panel include experts from outside the agency, including nonvoting members who represent consumer or industry interests.
This particular guidance does not cover the Medical Devices Dispute Resolution Panel (DRP) or radiation emitting product advisories such as the Device Good Manufacturing Practice Advisory Committee.
Though these panel discussions are nonbinding, the FDA takes the panel’s opinion under advisement when making regulatory decisions regarding a product's safety, efficacy, and classification.
According to the CDRH, a panel is typically consulted if there is a novel technology set to make a significant impact on current clinical practices, if there are issues of data integrity, or if the risks of the product seem to outweigh its possible benefits. The CDRH may also convene a panel if there are regulatory questions about classification, reclassification, or scientific questions related to specific types of devices rather than a specific product.
Panel meetings are arranged at the CDRH’s discretion, scheduled based on the availability of experts and venues, and announced at the Federal Register. Device developers are expected to submit relevant information in advance of the panel meeting date, and the guidance outlines a timeline of what information will be exchanged between the device sponsor and the agency prior to the panel.
The guidance also explains the panel voting process, teleconference guidelines, and regulations regarding open public hearings, during which interested persons may present information for a minimum of 60 minutes per panel hearing.
Once finalized, this guidance will replace the Guidance on Amended Procedures for Advisory Panel Meetings issued in 2000, and the Panel Review of Premarket Approval Applications published in 1991.
The FDA will accept comments on the draft for the next 60 days.