This ICR collects information from manufacturers, importers, and distributors of medical devices to disclose to health professionals and consumers specific information about themselves or their devices on the label or labeling of their devices. The primary users of the information disclosed on the label or in the labeling of devices are the health professionals who use or prescribe the device or the lay consumers who use the device. The labeling should contain sufficient information for these persons to use the device safely and effectively. FDA may use the information to determine whether there is reasonable assurance of the safety and effectiveness of the device for its intended use.
The latest form for Medical Device Labeling Regulations expires 2021-10-31 and can be found here.
Document Name |
---|
Supplementary Document |
Supporting Statement A |
Approved with change |
Revision of a currently approved collection | 2022-08-18 | |
Comment filed on proposed rule and continue |
Revision of a currently approved collection | 2022-03-10 | |
Approved without change |
Revision of a currently approved collection | 2021-10-12 | |
Approved without change |
No material or nonsubstantive change to a currently approved collection | 2021-06-16 | |
Approved without change |
Extension without change of a currently approved collection | 2018-09-13 | |
Approved with change |
Revision of a currently approved collection | 2015-01-30 | |
Approved with change |
Extension without change of a currently approved collection | 2011-08-10 | |
Approved without change |
Extension without change of a currently approved collection | 2008-06-27 | |
Approved without change |
Extension without change of a currently approved collection | 2005-04-07 | |
Approved without change |
New collection (Request for a new OMB Control Number) | 2002-01-25 |
Federal Enterprise Architecture: Health - Consumer Health and Safety