Zdrowie i gospodarka · 13.05.2014
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices." FDA developed this draft document to provide guidance about the appropriate use of national and international voluntary consensus standards in the preparation and evaluation of premarket submissions for medical devices. This document also discusses procedures for the appropriate use of consensus standards, both recognized and non- recognized, limitations on the use of consensus standards, and the content of a Declaration of Conformity to FDA-recognized consensus standards. This draft guidance is not final nor is it in effect at this time.