The CDRH issued the Procedures for Meetings of the Medical Devices Advisory Committee draft guidance on April 1, 2015. This draft guidance explains the processes for meetings of the Medical Devices Advisory Committee panels. Panel meetings provide an opportunity for addressing scientific, clinical, or public health issues.
Medical Device Advisory Committee Panels functions:
- Panels may give expertise for medical device premarket submissions under review. CDRH will use panel review for submissions such as: premarket notifications, de novo requests and humanitarian device exemptions.
- The CDRH may use a committee panel for advice on regulatory actions on a specific device type including general scientific matters or medical device safety and effectiveness.
- The FDA is required to seek a panel’s input as part of the classification of a preamendments device or as part of the process to reclassify a device.
Panel Meetings Process Highlights:
- All panel meetings are announced in the Federal Register. Relevant information may be submitted via http://www.regulations.gov before the panel meeting.
- Premarket Submission Panel Pack may include: FDA’s agenda, FDA’s Executive Summary, FDA’s questions for panel consideration, Sponsor’s Executive Summary, sections from the submission, information from the FDA, and information from the sponsor.
- Regulatory Issues Panel Pack may contain: FDA’s agenda, FDA’s Executive Summary, and FDA’s questions for the panel.
- During Premarket Submission panel meetings the sponsor should generally be provided 60 minutes to present information to the panel. Industry stakeholders who request time to speak in advance will generally have a 60 minute presentation slot.
- CDRH presents regulatory background information and its review of the scientific and/or clinical information for which panel input is requested. FDA typically presents the scientific and/or regulatory view of any issues and ask for guidance from the panel regarding FDA’s questions.
- All advisory committee meetings must include a minimum of 60 minutes dedicated to an open public hearing session.
- Approximately one hour should be designated for general panel deliberations, after which CDRH should ask the specific questions to the panel.
- A member must be present to participate in voting. All voting should be conducted in public view. The formal voting process is typically used for specific device marketing submissions. For Regulatory Issue meetings involving classifications or reclassifications, guidance documents, and other general issues brought to panel, the panel should be asked to discuss the issues and provide recommendations on questions asked by CDRH. For PMA meetings, the panel is typically expected to respond to three questions relating to: safety, effectiveness, and benefit versus risk for specific devices that are the subject of a PMA application.
- Teleconference panel meetings will generally be brief. These meetings are authorized to confirm the recommendations from a previous open panel meeting or where time does not permit a meeting to be held at a central location.