Issue Date: July 25, 1994
Issued by: Center for Devices and Radiological Health
Topic(s):
Status: Final
Points to Consider for Cervical Cytology Devices
This points-to-consider document supplements existing FDA guidance for premarket submission of in vitro diagnostic devices for approval or clearance. The information requested is intended to be comprehensive but may not be all inclusive. The emphasis is on FDA’s particular concerns in the review of cytology devices for gynecologic specimens.
Download the Guidance Document
