Medical Devices; Rescission of Substantially Equivalent Decisions and Rescission Appeal Procedures
Information
Type
Proposed Rule
Regulated products
Medical Devices
Published
January 16, 2001
Last updated
January 16, 2001
Description
Document number 01-1128. The Food and Drug Administration (FDA) is proposing regulations under which FDA may rescind a decision issued under the Federal Food, Drug, and Cosmetic Act (the act) that a device is substantially equivalent to a legally marketed device, and, therefore, may be marketed. In addition, under this proposal, a premarket notification (commonly known as a "510(k)") holder may request administrative review of a proposed rescission action. This proposed rule is being issued in order to standardize the procedures for considering rescissions.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)