Is Your Device Up for Ad Com Review? FDA Has Some Tips

New guidance from the U.S. FDA’s medical devices center aims to help manufacturers get the most benefit from meetings with agency advisory committees by explaining the uses of committee meetings and steps firms can take to prepare.

The Medical Devices Advisory Committee consists of 17 advisory panels whose topics range from plastic surgery devices to radiological products. These panels provide advice on regulatory issues, such as reclassification of preamendment devices, and premarket submissions.

Timelines

Premarket submission meetings are where most devicemakers will come into contact with MDAC and its panels.

The meetings typically involve a single device for which the manufacturer seeks marketing authorization — such as premarket approval applications, de novo requests and humanitarian device exemptions. Committee panelists give specific advice on the device under review and address scientific, clinical and public health issues that are relevant to the review.

The FDA will request a panel review when there is uncertainty about the risks versus benefits of the device or if there are major data quality or integrity issues with the submission, such as missing data and protocol deviations, the draft guidance says.

The guidance also describes what the FDA will do to prepare expert panelists for a meeting and sets a timeline for interactions between the agency and the sponsor leading up to the meeting.

Panel members will receive a packet with the meeting’s planned agenda, the agency’s summary of the issue, questions for the panel’s consideration, appropriate sections or excerpts from the device submission and other relevant information, such as scientific literature.

About 55 business days before the meeting, the FDA will send an information letter to the sponsor with an outline of the material it intends to include in the panel pack. Then, 42 days out the company should submit two versions—one complete and one redacted—of its proposed materials for the pack.

Between then and 22 days ahead of the meeting, the FDA will review the unredacted materials and provide feedback to the sponsor. This is the time to call out errors and correct the final version that will go into the panel pack, the guidance notes.

Between two and three weeks before the meeting, the FDA will send a final unredacted panel pack to panelists and the sponsor.

Slides to be viewed during the meeting should be exchanged five days prior to the meeting, and two days before the meeting the FDA will post the redacted briefing materials on its website.

The guidance also discusses panel deliberations and voting. While panel recommendations aren’t binding, the FDA often follows their advice.

All panel meetings include a public session during which interested parties can comment.

Comments on the draft guidance are due June 1. Read it at www.fdanews.com/04-01-15-CDRH.pdf. — Charlotte Astor