FDA Guidance on Submitting 510(k) for a Change to an Existing Device – Best Practices to Follow

  • By: Staff Editor
  • Date: December 02, 2011
Webinar All Access Pass Subscription Abstract:

The FDA has issued guidance on how to submit 510(k)s for changes to existing devices. This guidance details the types of significant changes that necessitate the need for submitting a 510(k).

This article describes the best practices that medical device manufacturers can follow in order to comply with this guidance.

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