Non-binding Feedback from FDA

The FDA released a Draft Guidance titled “Nonbinding Feedback After Certain FDA Inspections of Device Establishments”, on February 19, 2019.  It provides a very limited set of conditions where companies can request non-binding FDA feedback to the adequacy of planned corrective actions. The request must be submitted within 15 days of the issuance of the 483. Requests can only be made for 483 observations where:

  • It is likely to result in release of a product that may cause death or serious injury
  • Quality system deficiencies have resulted in, or would likely result in the production of nonconforming, violative, and/or defective finished device
  • The issue relates to an emerging safety issue that is likely to result in release of devices that could lead to cause death or serious injury.

This draft guidance provides information on how to submit such requests.

The full draft is at https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm631397.pdf

Schedule Discussion with John F. Murray, Jr.

John is currently providing telephone and face-to-face meetings to discuss:  Cybersecurity, Part 11, 483 Response, design controls expectations for software documentation, and other topics.

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