# Clinical Chemistry and Clinical Toxicology Devices; Classification of B-Type Natriuretic Peptide Test System
> **Food and Drug Administration** · Final rule. · Published 2001-02-28 · Effective 2001-02-28 · 66 FR 12733
## Document
- **Document number:** 01-4847
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 66 FR 12733
- **CFR reference:** 21 CFR 862
- **Publication date:** 2001-02-28
- **Effective date:** 2001-02-28
- **HHS docket:** Docket No. 00P-1675
## Abstract

The Food and Drug Administration (FDA) is classifying the B- type natriuretic peptide (BNP) test system into class II (special controls). The special control that will apply to this device is a guidance document entitled "Class II Special Control Guidance Document for B-Type Natriuretic Peptide Premarket Notifications; Final Guidance for Industry and FDA Reviewers." The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976, the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997. The agency is classifying these devices into class II (special controls) in order to provide a reasonable assurance of the safety and effectiveness of the device.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2001/02/28/01-4847/clinical-chemistry-and-clinical-toxicology-devices-classification-of-b-type-natriuretic-peptide-test)
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