Neurological and Physical Medicine Devices; Designation of Special Controls for Certain Class II Devices and Exemption From Premarket Notification
Information
Type
Proposed Rule
Regulated products
Published
April 5, 2010
Last updated
April 5, 2010
Description
Document number 2010-7637. The Food and Drug Administration (FDA) is proposing to amend certain neurological device and physical medicine device regulations to establish special controls for these class II devices and to exempt some of these devices from the premarket notification requirements of the Federal Food, Drug, and Cosmetic Act. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of draft guidance documents that would serve as special controls for each of these devices if the rule is finalized.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)