Devices

Workshop on Using Consensus Standards in Device Submissions

David McFarland

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FDA has announced a 12/7 public workshop on “Appropriate Use of Consensus Standards” to obtain public input on using them in premarket submissions for medical devices. The agency also plans to discuss “potential approaches to help facilitate the use of standards in premarket submissions,” according to a notice. Additionally, it will provide an overview of final guidance entitled “Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices.

Additionally, FDA is seeking feedback on:

  • Whether there are existing resources that it could improve to better assist medical device submitters with standards used in their submissions (e.g., guidance, Web sites).
  • Tools needed to help facilitate the use of FDA-recognized standards.
  • Resources needed to encourage the appropriate use of standards in medical device submissions.

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