# Medical Devices; 30-Day Notices and 135-Day PMA Supplement Review
> **Food and Drug Administration** · Final rule. · Published 1998-10-08 · Effective 1998-11-09 · 63 FR 54042
## Document
- **Document number:** 98-26928
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 63 FR 54042
- **CFR reference:** 21 CFR 814
- **Publication date:** 1998-10-08
- **Effective date:** 1998-11-09
- **HHS docket:** Docket No. 98N-0168
## Abstract

The Food and Drug Administration (FDA) is amending its regulations governing the submission and review of premarket approval (PMA) supplements to provide for the submission of a 30-day notice for modifications to manufacturing procedures or methods of manufacture. 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).

## Source
- [Federal Register document](https://www.federalregister.gov/documents/1998/10/08/98-26928/medical-devices-30-day-notices-and-135-day-pma-supplement-review)
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