FDA Compliance Programme Guidance on Inspections of Medical Devices Manufacturers

Medical devices manufacturers "fear" FDA inspections as well. Companies which have never had an FDA inspection often don't know how such an inspection is performed. They can find support in an FDA Manual published last year. The Compliance Programme Guidance Manual "Inspection of Medical Device Manufacturers" (7382.845) is composed of 72 pages divided in 6 parts and 5 attachments and provides guidance for FDA employees on how to perform such inspections. The manual is structured in:

Index
I: Background
II: Implementation
III: Inspectional
IV: Analytical
V: Regulatory/Administrative Follow-up
VI: References
Attachment A: Office of Compliance Organizational Chart
Attachment B: Office of In Vitro Diagnostic Devices Organizational Chart
Attachment C: Summary of MDR Reporting Requirements
Attachment D: Summary of Tracking Requirements
Attachment E: Summary of Corrections and Removals Requirements

In the manual, measures resulting from inspections are described in the Quality System Regulation (QSR (GMP requirements for medical devices), 21 CFR 820), Medical Device Reporting (MDR), 21 CFR 803), Medical Device: Reports of Corrections and Removals (21 CFR 806), Tracking Regulation (21 CFR 821), Correction and Removal Regulation (21 CFR 806), Registration and Listening Regulation (21 CFR 807). Parts III and V are particularly interesting for the GMP domain (21 CFR 820). Indeed, part III describes FDA's inspection strategy. A table presents 3 inspection levels  ("abbreviated", "comprehensive" and "follow-up") and 2 special cases ("for cause" and "risk based work plan") and explains the scope of inspections. The scope is based on the number of Quality System Inspection Technique (QSIT) subsystems. A subchapter deals with foreign inspections. Foreign inspections have to be performed as "Level 2" inspections ("comprehensive"). This means that the inspector checks the 4 main QSIT subsystems (Management Controls, Design Controls, CAPA and Production & Process Control). Part V presents how administrative follow-up to the point of goods seizure are handled following an inspection.

Conclusion: Medical devices manufacturers who expect an FDA inspection for the first time or have little experience should consult the document. This is also advisable for companies which have already been audited by the FDA. They still can find interesting information and details.

Please see the manual "Inspection of medical device manufacturers" for more detailed information.

Compiled by
Sven Pommeranz
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)