In the USA, medical devices are regulated by the Food and Drug Administration (FDA) with an aim to ensure safety and effectiveness of the devices. The Centre for Devices and Radiological Health (CDRH) is an FDA component and looks after this program.
Medical devices are classified into three categories based on the associated risk, namely: Class I, II and III. Class I devices will have least associated risk while class III devices will have the highest associated risk. Accordingly, regulatory control surges from Class I devices to Class III devices.
With respect to that, most of Class I devices are exempted from 510(k) premarket notification submission, while most of Class II devices are submitted for premarket notification. On the other hand, Class III devices need to go through the Premarket Approval Application (PMA) and other class III devices, which are exempted from PMA must submit a 510(k) notification to FDA.
Manufacturers must establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications. The quality systems for FDA-regulated products (food, drugs, biologics, and devices) are known as current good manufacturing practices (CGMP’s). CGMP requirements for devices in part 820 (21 CFR part 820) were first authorized by section 520(f) of the Federal Food, Drug, and Cosmetic Act (the act). Under section 520(f) of the act, FDA issued a final rule in the Federal Register of July 21, 1978 (43 FR 31 508), prescribing CGMP requirements for medical devices. This regulation became effective on December 18, 1978, and was codified under part 820
The QS regulation applies to finished device manufacturers who intend to commercially distribute medical devices. A finished device is defined in 21 CFR 820.3(l) as any device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized.
Certain components such as blood tubing and diagnostic x-ray components are considered by FDA to be finished devices because they are accessories to finished devices. A manufacturer of accessories is subject to the QS regulation.
Types of FDA Regulations for Medical Devices
- Establishment Registration & Medical Device Listing – 21 CFR Part 807
- Premarket Notification 510(k) – 21 CFR Part 807 Subpart E
- Premarket Approval (PMA) – 21 CFR Part 814
- Investigational Device Exemption (IDE) for clinical studies – 21CFR Part 812
- Quality System (QS) regulation 21 CFR Part 820
- Labelling requirements – 21 CFR Part 801
- Medical Device Reporting (MDR) – 21 CFR Part 803
- MAVEN has hands-on experience in developing FDA Class I, Class II and Class III devices for monitoring, diagnostics & imaging, wearable health, and telemedicine.
We provide consultancy in required expertise for compliance to IEC 60601-1/2/6, IEC 62304, IEC 62366, 510K and ISO 13485.