# Medical Devices; Exemptions From Premarket Notification: Class II Devices
> **Food and Drug Administration** · Final order. · Published 2018-06-05 · Effective 2018-06-05 · 83 FR 25910
## Document
- **Document number:** 2018-11879
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 83 FR 25910
- **CFR reference:** 21 CFR 862
- **Publication date:** 2018-06-05
- **Effective date:** 2018-06-05
- **HHS docket:** Docket No. FDA-2017-N-1129
## Abstract

The Food and Drug Administration (FDA or the Agency) is publishing an order to exempt a list of class II devices from premarket notification (510(k)) requirements, subject to certain limitations. This exemption from 510(k), subject to certain limitations, is immediately in effect for the listed class II devices. This exemption will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulations. FDA is also amending the codified language for the listed class II devices to reflect this final determination. FDA is publishing this order in accordance with the section of the Federal Food, Drug, and Cosmetic Act (FD&C Act) permitting the exemption of a device from the requirement to submit a 510(k).

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2018/06/05/2018-11879/medical-devices-exemptions-from-premarket-notification-class-ii-devices)
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