# Medical Devices; Exemptions From Premarket Notification for Class I and Class II Devices
> **Food and Drug Administration** · Final amendment; final order. · Published 2019-12-30 · Effective 2019-12-30 · 84 FR 71794
## Document
- **Document number:** 2019-27394
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 84 FR 71794
- **CFR reference:** 21 CFR 862
- **Publication date:** 2019-12-30
- **Effective date:** 2019-12-30
- **HHS docket:** Docket Nos. FDA-2017-N-1129 and FDA-2017-N-1610
## Abstract

The Food and Drug Administration (FDA, Agency, or we) identified a list of class I devices and class II devices that are now exempt from premarket notification requirements, subject to certain limitations. FDA published the lists of final determinations in accordance with procedures established by the 21st Century Cures Act (Cures Act). Although each classification regulation for each such type of device shall be deemed amended to incorporate such exemption, we are publishing this final order to amend the codified language for each listed class I and class II device's classification regulation to reflect the final determinations. FDA's action decreases regulatory burden on the medical device industry and eliminates private costs and expenditures required to comply with certain Federal regulations.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2019/12/30/2019-27394/medical-devices-exemptions-from-premarket-notification-for-class-i-and-class-ii-devices)
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