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FDA has been busy working on guidance documents, including Nonbinding Feedback After Certain FDA Inspections of Device Establishments.

Mike Drues of Vascular Sciences joins Jon Speer on the Global Medical Device Podcast this week to discuss the importance of this document and how it relates to 483 observances and warning letters for medical devices.

 

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Some of the highlights of the show include:

  • What prompted nonbinding feedback guidance, and is it necessary? CDRH’s increased number of site inspections resulted in more warning letters.
  • CDRH is more aggressive with annual inspections because some medical device companies and their employees do stupid things, instead of the right things.
  • Goal of guidance is to improve communications with medical device companies concerning corrective actions in response to inspectional observations.
  • There are differences between a 483 and warning letter. A 483 is an inspectional item with room for improvement; a warning letter indicates a serious violation.
  • Guidance Process: Inspection is performed, company receives a 483, analyzes the observation, generates a response, and FDA returns nonbinding feedback.
  • If company’s response is appropriately implemented, FDA states: Response appears to be adequate, partially adequate, or inadequate.
  • Nobody wants to receive a 483. It’s usually inevitable, but not the end of the world. Be proactive and respond appropriately to avoid escalation.
  • A company needs to respond to FDA in a timely manner, which is within 15 business days. FDA tries to return nonbinding feedback within 45 calendar days.

 

Links:

Nonbinding Feedback After Certain FDA Inspections of Device Establishments

FDA In Brief: FDA takes steps to improve communications with medical device companies concerning corrective actions in response to inspectional observations

CDRH Drafts Method to Provide Feedback on FDA Form 483 Citations

FDA Proposes More Formalized Form 483 Communications for Medical Devices

Mike Drues

Greenlight Guru

 

Quotes:

“CDRH is taking a much more aggressive approach to these inspections and issuing more warning letters.” Mike Drues

“There are some medical device companies and the people in them that have done, and continue to do, stupid things.” Mike Drues 

“The goal...is to improve communications with medical device companies concerning corrective actions in response to inspectional observations.” Mike Drues

“I’m kind of a fan of this guidance. It has the potential to promote more of an interactive or collaborative type of engagement.” Jon Speer

 


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