Draft Guidance for Industry and Food and Drug Administration Staff; The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications 510(k); Availability

2 organizations filed 2 public comments on Draft Guidance for Industry and Food and Drug Administration Staff; The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications 510(k); Availability, at the Food and Drug Administration. The comment window closed 5206d ago.

Abstract

Stephen Ripley (CBER)

Commenters (2)

• Advanced Medical Technology Associationtrade assoc.

  1 filing · confidence 97%
• Medical Imaging & Technology Alliancetrade assoc.

  1 filing · confidence 97%