Zdrowie i gospodarka · 14/10/1999

FDA Releases Draft Guidance for Premarket Notification Application for Processed Human Dura Mater

The FDA has released a draft guidance document outlining the requirements for a premarket notification application to establish the substantial equivalence of a processed human dura mater device to existing products, replacing a previous guidance dated June 26, 1990, and incorporating recommendations from the FDA TSE Advisory Committee meetings in 1997 and 1998.