FDA to hold digital mammography hearing

February 15, 1995

The Food and Drug Administration's radiological devices panel of the medical devices advisory committeewill be meeting on March 6 to discuss requirements for submissionsof digital mammography device approval applications. The meetingwill cover the FDA's

The Food and Drug Administration's radiological devices panel of the medical devices advisory committeewill be meeting on March 6 to discuss requirements for submissionsof digital mammography device approval applications. The meetingwill cover the FDA's proposal to regulate full-field-of-view digitalmammography products as class-three devices, a move that wouldrequire vendors to submit premarket approval applications (PMAs)to the FDA (SCAN 1/18/95).

The meeting will begin at 8 a.m. in Conference Room 20G inthe Corporate Building at the FDA's headquarters at 9200 CorporateBlvd., Rockville, MD. Industry comments before the meeting canbe directed to Dr. Steven C. Quay of Sonus Pharmaceuticals, whois serving as the industry representative on the radiologicaldevices panel. Dr. Quay can be reached at Sonus Pharmaceuticals,22026 20th Ave. SE, Suite 102, Bothell, WA 98021. His phone numberis 206/487-9500.