# Medical Devices; Device Tracking
> **Food and Drug Administration** · Final rule. · Published 2002-02-08 · Effective 2002-05-09 · 67 FR 5943
## Document
- **Document number:** 02-3076
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 67 FR 5943
- **CFR reference:** 21 CFR 821
- **Publication date:** 2002-02-08
- **Effective date:** 2002-05-09
- **HHS docket:** Docket No. 00N-1034
## Abstract

The Food and Drug Administration (FDA) is amending the medical device tracking regulation. FDA is making substantive changes to revise the scope of the regulation and add certain patient confidentiality requirements, and nonsubstantive changes to remove outdated references and simplify terminology. These revisions are made to conform the regulation to changes made in section 519(e) of the Federal Food, Drug, and Cosmetic Act (the act) by the FDA Modernization Act of 1997 (FDAMA), and to simplify certain requirements.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2002/02/08/02-3076/medical-devices-device-tracking)
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