# Medical Devices; 30-Day Notices and 135-Day PMA Supplement Review
> **Food and Drug Administration** · Direct final rule; withdrawal. · Published 1998-08-11 · 63 FR 42699
## Document
- **Document number:** 98-21470
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 63 FR 42699
- **CFR reference:** 21 CFR 814
- **Publication date:** 1998-08-11
- **HHS docket:** Docket No. 98N-0168
## Abstract

The Food and Drug Administration (FDA) published, in the Federal Register of April 27, 1998 (63 FR 20530), a direct final rule to implement the amendments to the premarket approval provisions of the Federal Food, Drug, and Cosmetic Act, as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA). The comment period closed on July 13, 1998. FDA is withdrawing the direct final rule because the agency received significant adverse comment.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/1998/08/11/98-21470/medical-devices-30-day-notices-and-135-day-pma-supplement-review)
---
*AI Analytics · CC0 1.0*