Devices: General Hospital and Personal Use Devices; Reclassification of Medical Device Data System
Information
Type
Proposed Rule
Regulated products
Medical Devices
Published
February 8, 2008
Last updated
February 8, 2008
Description
Document number E8-2325. The Food and Drug Administration (FDA) is proposing to reclassify, on its own initiative, the Medical Device Data System (MDDS) from class III (premarket approval) to class I (general controls). This action does not include medical device data systems with new diagnostic or alarm functions. FDA is also proposing that the MDDS be exempt from the premarket notification requirements when it is indicated for use only by a healthcare professional and does not perform irreversible data compression.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)