# Medical Devices; Reclassification of Tumor-Associated Antigen Immunological Test Systems
> **Food and Drug Administration** · Final rule. · Published 1997-12-17 · Effective 1996-09-19 · 62 FR 66003
## Document
- **Document number:** 97-32876
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 62 FR 66003
- **CFR reference:** 21 CFR 866
- **Publication date:** 1997-12-17
- **Effective date:** 1996-09-19
- **HHS docket:** Docket No. 95P-0136
## Abstract

The Food and Drug Administration (FDA) is announcing that it is codifying the reclassification of tumor-associated antigen immunological test systems intended as an aid in monitoring patients for disease progression or response to therapy or for the detection of recurrent or residual disease from class III (premarket approval) to class II (special controls). FDA is also announcing that it has issued an order in the form of a letter to Centocor, Inc., reclassifying serum tumor markers into class II. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 and the Safe Medical Devices Act of 1990.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/1997/12/17/97-32876/medical-devices-reclassification-of-tumor-associated-antigen-immunological-test-systems)
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