Zdrowie i gospodarka · 22.10.2002

Draft Guidance for Industry on Class II Special Controls Guidance Document: Human Dura Mater; Availability

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Class II Special Controls Guidance Document: Human Dura Mater; Draft Guidance for Industry and FDA." Elsewhere in this issue of the Federal Register, FDA is issuing a proposed rule to classify human dura mater into class II (special controls). This draft guidance document was developed as the special controls guidance. It also updates the information in the "Guidance for the Preparation of a Premarket Notification Application for Processed Human Dura Mater" issued on October 14, 1999. This guidance is neither final nor is it in effect at this time.