# Medical Devices; Exemption From Premarket Notification Requirements; Class I Devices; Technical Amendment
> **Food and Drug Administration** · Final rule; technical amendment. · Published 2001-07-25 · Effective 2001-07-25 · 66 FR 38786
## Document
- **Document number:** 01-17867
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 66 FR 38786
- **CFR reference:** 21 CFR 862
- **Publication date:** 2001-07-25
- **Effective date:** 2001-07-25
- **HHS docket:** Docket No. 01N-0073
## Abstract

The Food and Drug Administration (FDA) is amending the language in its medical device classification regulations for class I devices for consistency, to include in sections where it was not present, a specific reference to the limitations on exemptions from premarket notification requirements for each generic device classified. The specific reference language was included when some class I generic devices were first exempted under provisions of the Food and Drug Administration Modernization Act of 1997 (FDAMA). These amendments will provide the same reference for devices that were exempted before that time. The language is intended to conveniently provide the reference, and make the sections clear and easy to read. The status of the devices is not being changed.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2001/07/25/01-17867/medical-devices-exemption-from-premarket-notification-requirements-class-i-devices-technical)
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