# Medical Device Reporting: Manufacturer Reporting, Importer Reporting, User Facility Reporting, Distributor Reporting
> **Food and Drug Administration** · Direct final rule; withdrawal. · Published 1998-08-27 · 63 FR 45716
## Document
- **Document number:** 98-22926
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 63 FR 45716
- **CFR reference:** 21 CFR 803
- **Publication date:** 1998-08-27
- **HHS docket:** Docket No. 98N-0170
## Abstract

The Food and Drug Administration (FDA) published in the Federal Register of May 12, 1998, a proposed rule (63 FR 26129) and a direct final rule (63 FR 26069) to implement amendments to the medical device reporting provisions of the Federal Food, Drug, and Cosmetic Act, as amended by the FDA Modernization Act of 1997 (FDAMA). The comment period closed July 27, 1998. FDA is withdrawing the direct final rule because the agency received significant adverse comment.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/1998/08/27/98-22926/medical-device-reporting-manufacturer-reporting-importer-reporting-user-facility-reporting)
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