Most Class I devices and a few Class II devices are exempt from the premarket notification [510(k)] requirements subject to the limitations on exemptions. However, these devices are not exempt from other general controls. All medical devices must be manufactured under a quality assurance program, be suitable for the intended use, be adequately packaged and properly labeled, and have establishment registration and device listing forms on file with the FDA.
A few Class I devices are additionally exempt from the GMP requirements with the exception of complaint files and general record keeping requirements.
Class I/II Devices Exempt from 510(k) and class I Devices Exempt from GMPs
Devices exempt from 510(k) are:
- preamendment devices not significantly changed or modified; or
- Class I/II devices specifically exempted by regulation.
For purposes of 510(k) decision-making, the term "preamendment device" refers to devices legally marketed in the U.S. by a firm before May 28, 1976 and which have not been:
- significantly changed or modified since then; and
- for which a regulation requiring a PMA application has not been published by FDA.
Devices meeting this description are referred to as "grandfathered" and do not require a 510(k).
This website contains a listing of medical devices exempt from 510(k) and Good Manufacturing Practices (GMP) compiled from Title 21 Code of Federal Regulations (CFR) and recent federal register announcements on class I exemptions and class II exemptions.
The Food, Drug and Cosmetic Act under section 513(d)(2)(A) authorizes FDA to exempt certain generic types of Class I devices from the premarket notification [510(k)] requirement. FDA has exempted over 800 generic types of Class I devices and 60 class II devices from the premarket notification requirement. The 510(k) exemption is with certain limitations, which are so noted in ".9" of each chapter. It is important to confirm the exempt status and any limitations that apply with 21 CFR Parts 862-892 or the PRODUCT CODE CLASSIFICATION DATABASE or subsequent FR announcements on class I exemptions and class II exemptions.
If a manufacturer's device falls into a generic category of exempted Class I devices as defined in 21 CFR Parts 862-892, a premarket notification application and FDA clearance is not required before marketing the device in the U.S.
Requirements for Class I/II Exempt Devices
Even though a 510(k) is not required, it is necessary to meet other requirements for marketing. These include: