FDA Feedback after an Inspection at a Medical Device Manufacturer

Recommendation

11/12 February 2025
Heidelberg, Germany

Combination Products
Medicinal Products/Drugs meet Medical Devices

In a draft guideline, the FDA informs that in future they will offer (nonbinding) feedback following an FDA inspection at a medical device manufacturer. What does this mean?

Over a total of 8 pages, the FDA describes the procedure of nonbinding feedback following an inspection at a medical device manufacturer. The request for nonbinding feedback should come from the person to whom the Form FDA 483 was addressed. Alternatively, someone who can show that he or she can act responsibly for the inspected company can also make a request. The request should be made in a "timely manner", i.e. within 15 working days. In an ideal case, the request should be made together with the reply to the 483 document but as a separate document with a separate "cover letter". This cover letter should include the following:

A header with a request for nonbinding feedback
The name, address, telephone number and email address of the person submitting the request.
The name, address, and FDA Establishment Identification (FEI) number of the establishment inspected, including inspection date.
A justification describing how the request fulfils at least one of the eligibility criteria (reference to FD&C Act)

Thereafter, the guideline mentions criteria that justify nonbinding feedback. One example is an inadequate QM system that could lead to a defective product. Furthermore, the request should address the inspection result for which the nonbinding feedback should be given.

After reviewing the request, the FDA will respond within 45 calendar days. FDA's nonbinding feedback should explain whether the proposed actions to address inspectional observations are adequate, partially adequate, or inadequate. The nonbinding feedback is intended to assist the inspected company in processing the inspection defects, but is, as the guideline's name suggests, not binding.

You can find the draft guideline entitled "Nonbinding Feedback After Certain FDA Inspections of Device Establishments" on the FDA website.