New FDA Guide on Inspections of Medical Device Manufacturers

Recommendation

23-25 April 2024

Cleaning Validation AND Pre-Course Workshop: Impact of Annex 1 Revision on Cleaning Validation - Live Online Training

With the amendment of the FDA Reauthorization Act (FDARA) in August 2017, a FDA draft guideline entitled "Review and Update of Device Establishment Inspection Process and Standards" on FDA inspections of medical device manufacturers was also noted. This draft has now been finalized. It is based on the FDARA and is supposed to be used for the harmonization and the interpretation of the changes in the act.

With six pages the guideline is not very extensive. The final document's content is very similar to the draft document. Before a domestic FDA inspection of a medical device manufacturer, the FDA investigator informs the company concerned by telephone at least five calendar days before the inspection. In the case of inspections abroad, this can be more days. In any case, the type of inspection (surveillance inspection or pre-approval) should be mentioned in the announcement. Documents that will be inspected during the inspection should also be named in advance. As a rule, the duration of an inspection (abbreviated or comprehensive) is defined in the draft as 3-6 consecutive days. Depending on the scope of the inspection (e.g. after recalls), this period may be exceeded, but this should be communicated to the company by the FDA. 

If time and circumstances permit, all observations made by the investigator should be discussed with management, if necessary on a daily basis, to avoid errors and misunderstandings.

You can find the Guidance for Industry on the FDA Website.