# Medical Devices; Establishment Registration and Device Listing for Manufacturers and Distributors of Devices
> **Food and Drug Administration** · Direct final rule. · Published 1998-09-29 · Effective 1999-02-11 · 63 FR 51825
## Document
- **Document number:** 98-25796
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 63 FR 51825
- **CFR reference:** 21 CFR 807
- **Publication date:** 1998-09-29
- **Effective date:** 1999-02-11
- **HHS docket:** Docket No. 98N-0520
## Abstract

The Food and Drug Administration (FDA) is amending certain regulations governing establishment registration and device listing by domestic distributors. These amendments are being made to implement revisions to the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Food and Drug Modernization Act of 1997 (FDAMA). Elsewhere in this issue of the Federal Register, FDA is publishing a companion proposed rule, under FDA's usual procedures for notice and comment, to provide a procedural framework to finalize the rule in the event the agency receives any significant adverse comment and withdraws the direct final rule.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/1998/09/29/98-25796/medical-devices-establishment-registration-and-device-listing-for-manufacturers-and-distributors-of)
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