# Medical Device Classification Procedures: Incorporating Food and Drug Administration Safety and Innovation Act Procedures
> **Food and Drug Administration** · Final rule. · Published 2018-12-17 · Effective 2019-03-18 · 83 FR 64443
## Document
- **Document number:** 2018-27015
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 83 FR 64443
- **CFR reference:** 21 CFR 860
- **Publication date:** 2018-12-17
- **Effective date:** 2019-03-18
- **HHS docket:** Docket No. FDA‐2013-N-1529
## Abstract

The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend its regulations governing classification and reclassification of medical devices to conform to the applicable provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA). FDA is also making additional changes unrelated to the FDASIA requirements, to update its regulations governing the classification and reclassification of medical devices. FDA is taking this action to codify the procedures and criteria that apply to the classification and reclassification of medical devices and to provide for classification of devices in the lowest regulatory class consistent with the public health and the statutory scheme for device regulation.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2018/12/17/2018-27015/medical-device-classification-procedures-incorporating-food-and-drug-administration-safety-and)
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