# Medical Devices; Medical Device Classification Regulations To Conform to Medical Software Provisions in the 21st Century Cures Act
> **Food and Drug Administration** · Final rule. · Published 2021-04-19 · Effective 2021-04-19 · 86 FR 20278
## Document
- **Document number:** 2021-07860
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 86 FR 20278
- **CFR reference:** 21 CFR 862
- **Publication date:** 2021-04-19
- **Effective date:** 2021-04-19
- **HHS docket:** Docket No. FDA-2018-N-1440
## Abstract

The Food and Drug Administration (FDA, Agency, or we) is amending certain classification regulations to reflect changes to the Federal Food, Drug, and Cosmetic Act (FD&C Act) made by the 21st Century Cures Act (the Cures Act). The Cures Act amended the definition of a device in the FD&C Act to exclude certain software functions. FDA is taking this action so that its regulations conform to the medical software provisions in the Cures Act.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2021/04/19/2021-07860/medical-devices-medical-device-classification-regulations-to-conform-to-medical-software-provisions)
---
*AI Analytics · CC0 1.0*