Most Class I and Class II devices are exempt from premarket notification [510(k)] requirements. They may also be exempt from the current Device Good Manufacturing Practices (GMP), requirements under 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 expressly exempt from those requirements as indicated in the regulation for that device type.
To determine whether a device is exempt from 510(k) or GMP requirements, search the FDA’s Product Classification database.
On this page:
- 510(k) Exemptions
- Cures Act Exemptions
- Quality System Regulation/Good Manufacturing Practices Exemptions
Most class I and some class II devices are exempt from 510(k) requirements, subject to certain limitations (see section 510(l)(1) of the Federal Food, Drug, and 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 (see sections 510(l) and 510(m) of the Federal Food, Drug, and Cosmetic (FD&C) Act). Devices which may not be subject to 510(k) requirements include:
- Preamendments devices (please refer to FDA’s guidance “Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements”);
- Class I devices specifically exempted by FDA or classified as class I under section 513 (with certain exceptions); and c
- 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 class I device is not exempt from 510(k) notification requirements if it is intended for a use of substantial importance in preventing impairment of health, or presents a potential unreasonable risk of illness or injury.
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. Exemptions to the premarket notification requirements of 510(k) apply only to those devices that have existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type. General limitations to exemptions for a generic type of class I or class II device are set forth in each of the device classification regulations (21 CFR 862.9 through 892.9). Thus, a manufacturer of an exempted device is still required to submit a premarket notification before introducing a device or delivering it for introduction into commercial distribution when the device meets any of the conditions described in §§ 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 (see the examples in the table below). 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.
Cures Act Exemptions
Section 3054 of the 21st Century Cures Act amended sections 510(l) and 510(m) of the FD&C Act. As amended, these provisions require the FDA to identify within a certain timeframe and through publication in the Federal Register, any type of class I or class II device, respectively, that the FDA determines no longer requires a report under section 510(k) of the FD&C Act to provide reasonable assurance of safety and effectiveness.
The table below identifies the actions taken by the FDA after the passage of the Cures Act pursuant to these statutory requirements. This does not include exemptions that were implemented as a result of petitions requesting exemption from premarket notification requirements.
To identify the specific product codes impacted, click the Federal Register Notice link.
|Date||Federal Register Notice||Class of Device||Total Number of Product Codes Impacted|
|07/22/2020||85 FR 44186||Class II||5|
|06/05/2018||83 FR 25910||Class II||5|
|05/17/2018||83 FR 22846||Class II - Surgical Apparel||1|
|11/07/2017||82 FR 51567||Class II - Autosomal Recessive Carrier Screening Gene Mutation Detection Systems||1|
|07/11/2017*||82 FR 31976||Class II||336|
|04/13/2017*||82 FR 17841||Class I||66|
*These notices included lists of product codes that FDA identified as no longer requiring premarket notification in accordance with procedures established by the 21st Century Cures Act. On December 30. 2019, FDA published a final order (84 FR 71794) to amend the associated codified language to reflect these exemptions.
Quality System Regulation/Good Manufacturing Practices Exemptions
All medical devices are subject to the Quality System Regulation (21 CFR 820), including “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.
- Class I/II Exemptions
- Premarket Notification 510(k)
- Preamendment Status
- Establishment Registration and Device Listing
- Device Labeling
- Quality System (QS) Regulation/Medical Device Good Manufacturing Practices
- Quality System Regulation Labeling Requirements
- Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements