# Medical Device Reporting: Manufacturer Reporting, Importer Reporting, User Facility Reporting, and Distributor Reporting
> **Food and Drug Administration** · Direct final rule. · Published 1998-05-12 · Effective 1998-09-24 · 63 FR 26069
## Document
- **Document number:** 98-12614
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 63 FR 26069
- **CFR reference:** 21 CFR 803
- **Publication date:** 1998-05-12
- **Effective date:** 1998-09-24
- **HHS docket:** Docket No. 98N-0170
## Abstract

The Food and Drug Administration (FDA) is amending its regulations governing reporting by manufacturers, importers, distributors, and health care (user) facilities of adverse events related to medical devices. Amendments are being made to implement revisions to the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA). FDA is publishing these amendments in accordance with its direct final rule procedures. 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 a significant adverse comment and withdraws this direct final rule.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/1998/05/12/98-12614/medical-device-reporting-manufacturer-reporting-importer-reporting-user-facility-reporting-and)
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