Medical Devices; Radiology Devices; Reclassification of Full Field Digital Mammography System
Information
Type
Proposed Rule
Regulated products
Medical Devices
Published
May 30, 2008
Last updated
May 30, 2008
Description
Document number E8-12120. The Food and Drug Administration (FDA) is proposing to reclassify the full field digital mammography (FFDM) system from class III (premarket approval) to class II (special controls). The device type is intended to produce full field digital x-ray images of the breast. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the draft guidance document entitled "Class II Special Controls Guidance Document: Full Field Digital Mammography System" that would serve as the special control for the device, if FDA reclassifies this device type.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)