20/21 March 2024
With the entry into force of the FDA Reauthorization Act (FDARA) in August 2017, sections on the inspection of medical device manufacturers in the USA and abroad also became effective. A draft document from the FDA entitled "Review and Update of Device Establishment Inspection Process and Standards" on FDA inspections of medical device manufacturers has been issued for some time now to further harmonize and interpret the changes.
Prior to a domestic FDA inspection of a medical device manufacturer, the FDA investigator shall inform the company concerned by telephone at least five calendar days prior to the inspection. In the case of inspections abroad, the information can be given more than five calendar days before the inspection. In any case, the type of inspection (abbreviated, comprehensive or pre-approval) should be stated in the phone call. Documents that are inspected during the inspection should also be mentioned in advance. The duration of an inspection (abbreviated or comprehensive) in the draft is usually 3-6 consecutive days. Depending on the scope of the inspection (e.g. following recalls), this period may also be extended, but this should be communicated to the company by the FDA.
If time and circumstances permit, all the observations made by the investigator should be discussed with the management - on a daily basis if necessary - to avoid errors and misunderstandings.
For more details please see the draft document entitled "Review and Update of Device Establishment Inspection Process and Standards".