# Medical Devices; Exemptions From Premarket Notification: Class II Devices
> **Food and Drug Administration** · Final amendment; final order. · Published 2020-07-22 · Effective 2020-07-22 · 85 FR 44186
## Document
- **Document number:** 2020-15256
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 85 FR 44186
- **CFR reference:** 21 CFR 884
- **Publication date:** 2020-07-22
- **Effective date:** 2020-07-22
- **HHS docket:** Docket No. FDA-2019-N-2686
## Abstract

The Food and Drug Administration (FDA or the Agency) is publishing an order setting forth the Agency's final determination 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 list of class II devices. The 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 list of class II devices to reflect this final determination. FDA is publishing this order in accordance with the Federal Food, Drug, and Cosmetic Act (FD&C Act).

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2020/07/22/2020-15256/medical-devices-exemptions-from-premarket-notification-class-ii-devices)
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