Postmarket Surveillance
Information
Type
Proposed Rule
Regulated products
Published
August 29, 2000
Last updated
August 29, 2000
Description
Document number 00-21827. The Food and Drug Administration (FDA) is proposing to implement the postmarket surveillance (PS) provisions of the Federal Food, Drug, and Cosmetic Act (the act), as amended by the FDA Modernization Act of 1997 (FDAMA). The purpose of this proposed rule is to provide for the collection of useful data or other information necessary to protect the public health and to provide safety and effectiveness information about devices.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)