Class I / II Exemptions
Certain Class I and Class II devices are exempt from premarket notification [510(k)] requirements as well as the Medical Device Good Manufacturing Practices (GMPs), also referred to as the Quality System (QS) Regulation.
A Class I or Class II device that is exempt from 510(k) requirements must still comply with other requirements (known as regulatory controls) unless the device is explicitly exempt from those requirements as indicated in the regulation for that device type.
Anyone can determine whether a device is exempt from 510(k) or GMP requirements by searching the FDA’s Product Classification database.
Most Class I and some Class II devices are exempt from 510(k) requirements, subject to certain limitations (see sections 510(l) and 510(m) of the Federal Food, Drug & Cosmetic Act). A device may be exempt from 510(k) requirements if the FDA determines that a 510(k) is not required to provide reasonable assurance of safety and effectiveness for the device. Devices which may be exempt from 510(k) requirements are:
- Preamendments devices; and
- Class I and Class II devices specifically exempted by the FDA.
The term “preamendments device” refers to a device legally marketed in the U.S. before the enactment of the Medical Device Amendments on May 28, 1976 and that has not been:
- Significantly changed or modified since then; and
- For which the FDA has not determined a Premarket Approval (PMA) application is needed to provide reasonable assurance of the device’s safety and effectiveness.
A listing of Class I and Class II devices exempt from 510(k) requirements is available on the Medical Device Exemptions 510(k) and GMP Requirements website. General limitations to the exemptions are found in Title 21 of the Code of Federal Regulations (CFR) in sections 862.9 through 892.9. Additionally, the FDA may partially limit the exemption from 510(k) requirements to specific devices within a classification regulation. It is important to confirm a device’s 510(k) exemption status and any limitations that may apply.
Other helpful resources include 21 CFR 862-892, the Product Classification database and the FDA’s prior exemption announcements published in the Federal Register (for example, FDA-2017-N-1129). The Division of Industry and Consumer Education (DICE) within the FDA’s Center for Devices and Radiological Health can also help you identify the appropriate requirements for your device.
Quality System Regulation/Good Manufacturing Practices Exemptions
All medical devices are subject to the Quality System Regulation (21 CFR 820), also referred to as the “Current Good Manufacturing Practices” or “Good Manufacturing Practices,” unless there is an exception or exemption noted in 21 CFR 820. Regardless of the Class, you should refer to the device’s specific classification regulation to confirm regulatory requirements.