The Food and Drug Administration (FDA) has made available the final version of the “Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices. Guidance for Industry and Food and Drug Administration Staff” Guidance, providing medical device manufacturers and FDA staff information on the appropriate use of national and international voluntary Standards for the preparation and evaluation of premarket submissions for Medical Devices (510 (k), PMA, De Novo, etc.).

The Guidance:

  • Clarifies the regulatory expectations of the agency (the regulatory framework) for the appropriate use of voluntary standards in pre-market requests;
  • Describes the procedures and policies for the proper use of voluntary Standards;
  • Describes how the FDA personnel intends to rely on these Standards during the review process;
  • Describes the contents of the Declaration of Conformity (DoC) in terms of voluntary Standards;
  • Describes the general use Standards when the use of DoC is not appropriate for the purposes of premarket applications.

Please note that the use of voluntaryStandards is, in fact, not mandatory in premarket submissions, but can certainly simplify the review process and streamline the market entry for safe and effective Medical Devices.