FDA Class I Devices
The FDA has exempted most Class I medical devices (except Reserved Devices) from the FDA 510(k) Premarket Notification, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and January 16, 1996.
If your medical device falls into a generic category of exempted FDA Class I devices (as defined in 21 CFR Parts 862-892), an FDA 510(k) Premarket Notification Clearance may not be necessary, unless you have introduced a new technology or you have modified / changed / exceeded the intended use.
However an FDA Establishment Registration is still required and you must implement a Quality System compliant with 21 CFR Part 820.
FDA Class II Devices
FDA have also published a list of Class II medical devices (Special Controls) subject to certain limitations, which are now exempt from the FDA 510(k) Premarket Notification requirements under the 1997 FDA Modernization Act . Please note that Class II medical devices and most Class I medical devices are NOT exempt from FDA Good Manufacturing Practices (GMP) requirements.
FDA Class I and Class II exempt medical devices:
- PART 862 – CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
- PART 864 – HEMATOLOGY AND PATHOLOGY DEVICES
- PART 866 – IMMUNOLOGY AND MICROBIOLOGY DEVICES
- PART 868 – ANESTHESIOLOGY DEVICES
- PART 870 – CARDIOVASCULAR DEVICES
- PART 872 – DENTAL DEVICES
- PART 874 – EAR, NOSE, AND THROAT DEVICES
- PART 876 – GASTROENTEROLOGY-UROLOGY DEVICES
- PART 878 – GENERAL AND PLASTIC SURGERY DEVICES
- PART 880 – GENERAL HOSPITAL AND PERSONAL USE DEVICES
- PART 882 – NEUROLOGICAL DEVICES
- PART 884 – OBSTETRICAL AND GYNECOLOGICAL DEVICES
- PART 886 – OPHTHALMIC DEVICES
- PART 888 – ORTHOPEDIC DEVICES
- PART 890 – PHYSICAL MEDICINE DEVICES
- PART 892 – RADIOLOGY DEVICES
Please note that only specific medical devices within the categories above qualify for an FDA 510(k) Premarket Notification exemption (not the entire category).