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Mike on Medtech: Guidance on Medical Device Changes Submitted to FDA

Mike on Medtech: Guidance on Medical Device Changes Submitted to FDA

In August, the FDA released guidances offering insight on what changes need to be reported to the agency.

By Sean Fenske, Editor09.13.16


In this episode of Mike on Medtech, MPO/ODT editor Sean Fenske discusses two recently released guidances that address when changes to devices need to be submitted to the FDA with regulatory expert, Mike Drues of Vascular Sciences.

Questions addressed include:
  • Overview of what the guidances cover
  • How software changes are addressed
  • Making changes to an existing device
  • The difference between a letter-to-file, special 510(k), and PMA supplement
  • Changes made to the manufacturing process
  • What happens when a change isn't reported properly
  • Impact of confusion over changes to medical device development and innovation
Review the full guidance documents at:
Deciding When to Submit a 510(k) for a Change to an Existing Device [PDF]
Deciding When to Submit a 510(k) for a Software Change to an Existing Device [PDF]
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