By Stewart Eisenhart, Emergo Group
New guidance from the US Food and Drug Administration explains the role of specialized advisory panels in medical device regulatory issues including classification and marketing authorization determinations.
According to the guidance, the FDA’s Center for Devices and Radiological Health (CDRH) relies on input from 17 panels of the Medical Devices Advisory Committee to make determinations regarding device safety and effectiveness. Information on committee panels is intended to provide US market registrants as well as CDRH staff a better understanding of how these panels can affect market authorization decisions and regulatory requirements.
Medical Device Advisory Panel meetings are typically convened at the FDA’s request for two key reasons: premarket submission advice and/or regulatory issues.
Premarket submission advice: FDA reviewers may seek committee input on individual device premarket submissions, including considerations on any public health or scientific issues related to a particular device under review. Advisory committee input may be sought in cases where novel technologies are utilized, clinical data quality or integrity is questionable, or where clinical study results raise doubts about a device’s benefits versus risks to public health.
Regulatory issues: Advisory panels may also be called upon to advise on agency regulatory actions or scientific issues, according to the guidance. Regulatory issues include classification and reclassification considerations, as well as scientific issues related to device types but not individual devices.
In meetings held to determine marketing authorization, classification or reclassification of particular devices, manufacturers or sponsors of the devices under consideration may participate and argue their cases before advisory panels. Following presentations by sponsors and CDRH representatives, advisory committees conduct open public hearings. Finally, panels conduct their own internal deliberations, notify CDRH and sponsors of any lingering questions, and then vote on whether the devices they’re scrutinizing meet manufacturers’ safety and effectiveness claims.
