Clinical Chemistry and Clinical Toxicology Devices; Classification of B-Type Natriuretic Peptide Test System
Information
Type
Rule
Regulated products
Medical Devices
Published
February 28, 2001
Last updated
February 28, 2001
Description
Document number 01-4847. 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.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)