Current Good Manufacturing Practice (cGMP)

What does cGMP mean?

Current Good Manufacturing Practice describes the legally enforceable manufacturing and quality-system requirements for regulated products: the facilities, equipment, personnel, processes, records and controls behind production. The word "current" signals that compliance is not frozen at the date a rule was written. For medical devices, the FDA explains the current framework through its Quality Management System Regulation.

Where do cGMP requirements for medical devices live?

Device cGMP requirements are codified at 21 CFR Part 820. Since 2 February 2026 that part operates as the Quality Management System Regulation (QMSR), which incorporates ISO 13485 by reference together with FDA-specific provisions. Drug cGMP sits principally in 21 CFR Parts 210 and 211, so combination products and companies spanning both categories must map the requirements that apply to each constituent and operation.

How does the FDA enforce device cGMP?

The FDA evaluates compliance through establishment inspections and other oversight. Objectionable conditions observed during an inspection may be listed on an FDA Form 483; significant violations can escalate to a Warning Letter, import alert, seizure or injunction. A device manufactured without compliance with applicable cGMP requirements may be adulterated under the Federal Food, Drug, and Cosmetic Act even when no defect has yet been demonstrated in an individual unit.

Is ISO 13485 certification the same as FDA compliance?

No. ISO 13485 certification is issued by a certification body against the standard. The QMSR incorporates ISO 13485, but it also retains FDA-specific requirements and FDA determines regulatory compliance through its own oversight. A certificate can support a global quality strategy; it is not a substitute for meeting Part 820. Manufacturers planning a United States entry therefore assess their ISO 13485 system against the incorporated standard and the QMSR's additional provisions.