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Medical Devices / Regulatory Affairs

FDA Issues Draft Guidance on Requests for Nonbinding Feedback After Inspections

Feb. 22, 2019

The FDA issued draft guidance on requests for nonbinding feedback from the agency after inspections of device facilities.

Under the Food, Drug and Cosmetic Act, the agency is required to provide nonbinding feedback on inspection observations. Sponsors who have received a Form 483 may request feedback no later than 15 business days after the 483 is issued.

If the company is also submitting a response to a 483, the agency recommends including the response and feedback request as two documents in the same submission.

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