Core 21 CFR Parts for FDA Medical Device Regulation

The FDA (US Food and Drug Administration) regulatory framework for medical devices consists of multiple parts of 21 CFR (Code of Federal Regulations) Parts 800–898 (Subchapter H). These regulations cover the entire life cycle from device development and manufacturing to post-market surveillance. The chart below gives an overview of the core Parts of medical device regulation:

How the 21 CFR Parts connect and cover the entire life cycle

Every stage of a medical device’s journey, from development to withdrawal from the market, is governed by a corresponding Part:

Example compliance route: a Class II in vitro diagnostic (IVD) reagent

Taking a manufacturer of a Class II in vitro diagnostic reagent as an example, its compliance process must cover the following key steps:

Registration and listing: complete establishment registration and device listing under Part 807.
Pre-market submission: submit a 510(k) under Part 807 demonstrating that the product is substantially equivalent to a legally marketed predicate device.
Quality management: establish and operate a quality management system in accordance with Part 820 to ensure the production process complies with requirements.
Labelling and traceability: apply the UDI as required by Part 830 and upload the information to the GUDID database in a timely manner.
Post-market surveillance: report adverse events such as deviations in test results under Part 803 and initiate CAPA (corrective and preventive action) at the same time; where the FDA orders postmarket surveillance under Part 822, conduct the PMS study under Part 822 to continuously track product risks; and if the device is subject to tracking requirements, establish a device tracking system under Part 821

Summary

The FDA’s medical device regulatory system forms a closed loop through the various Parts of 21 CFR – from product classification, registration and listing and pre-market review to production quality control and post-market surveillance – safeguarding patient safety across the entire chain. Companies need to meet the requirements of the relevant Parts according to the device’s risk class (Class I/II/III) and make full use of official FDA resources (such as the GUDID database and the MDR adverse event reporting system) to optimise their compliance processes. The public can also look up specific Parts on the FDA website and follow device recalls and adverse events, helping to maintain the safety and effectiveness of medical devices.

As a professional organisation specialising in medical device regulations and quality systems, Everbiz is committed to sharing practical experience of FDA, NMPA, GMP, CE MDR/IVDR, MDSAP and other regulations and standards to help industry clients achieve compliance efficiently. If you have any questions or requirements, please contact us at any time.

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