Clients often ask Emergo if their product requires a 510(k). Shown below is a breakdown of FDA 510(k) exemptions listed by device class.
Class 1 Devices
The FDA has exempted most Class 1 devices with the exception of "Reserved Devices" from the Premarket Notification requirement, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and January 16, 1996.
If your device falls into a generic category of exempted Class 1 devices as defined in 21 CFR Parts 862-892, a Premarket Notification 510(k) clearance may not be required unless you are introducing a new and unique technology, or unless you modify/change/exceed the intended use. However, you are required to register your establishment with the FDA by registering your company and listing the medical device(s) using the FDA FURLS online registration system, and implement a quality system compliant with 21 CFR Part 820.
Class 2 Devices
The Food and Drug Administration (FDA) has also published a list of Class 2 (special controls) devices subject to certain limitations, that are now exempt from the Premarket Notification requirements under the Food and Drug Administration Modernization Act of 1997. Please note that Class 2 devices and most Class I devices are NOT exempt from GMP requirements.
THE LIST BELOW IS PROVIDED FOR YOUR BENEFIT TO HELP YOU DETERMINE IF YOUR DEVICE IS EXEMPT FROM THE FDA 510(k) PROCESS. ONLY SPECIFIC DEVICES WITHIN THESE CATEGORIES QUALIFY, NOT THE ENTIRE CATEGORY. PLEASE VISIT THE FDA MEDICAL DEVICE CLASSIFICATION DATABASE TO LEARN MORE: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/C...
Some Class 1 and Class 2 devices in these categories are exempt from 510(k):
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