The FDA on Friday issued draft guidance on requests for nonbinding feedback from the agency after inspections of device facilities.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. The request should be submitted to the same agency contact identified to receive the response to the 483.
Feedback requests should include full information on the establishment and the inspection dates, as well as a justification of the request under the FD&C Act. The justification may relate to specific FDA observation, multiple observations or all observations.
“Requestors should explain in detail how each individual observation meets one or more of the eligibility criteria within the justification,” the agency says.
The request should include proposed actions, including a detailed description and timeline. If none of the eligibility criteria are met, the statute does not require FDA to provide nonbinding feedback regarding proposed action.
Read the draft guidance here: www.fdanews.com/02-15-19-Feedback.pdf. — Zack Budryk