# Medical Devices; Custom Devices; Technical Amendment
> **Food and Drug Administration** · Final rule; technical amendment. · Published 2016-10-12 · Effective 2016-10-12 · 81 FR 70339
## Document
- **Document number:** 2016-24438
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 81 FR 70339
- **CFR reference:** 21 CFR 807
- **Publication date:** 2016-10-12
- **Effective date:** 2016-10-12
- **HHS docket:** Docket No. FDA-2016-N-2518
## Abstract

The Food and Drug Administration (FDA or Agency) is amending its regulations on the definition of a custom device so as to include new enumerated statutory requirements for custom devices under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA). This new provision, under FDASIA, amends the existing custom device exemption and introduces new concepts and procedures applicable to custom devices. This action is being taken to align the regulations with the FD&C Act.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2016/10/12/2016-24438/medical-devices-custom-devices-technical-amendment)
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