Medical Devices; Medical Device Reporting; Baseline Reports; Companion to Direct Final Rule
Information
Type
Proposed Rule
Regulated products
Medical Devices
Published
June 13, 2008
Last updated
June 13, 2008
Description
Document number E8-13349. The Food and Drug Administration (FDA) is proposing to amend its medical device reporting regulations to remove a requirement for baseline reports that the agency deems no longer necessary. Currently, manufacturers provide baseline reports to FDA that include the FDA product code and the premarket approval or premarket notification number. Because most of the information in these baseline reports is also submitted to FDA in individual adverse event reports, FDA is proposing to remove the requirement for baseline reports. The removal of this requirement would eliminate unnecessary duplication and reduce the manufacturer's reporting burden. This proposed rule is a companion document to the direct final rule published elsewhere in this issue of the Federal Register.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)