Display Devices for Diagnostic Radiology; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

Streszczenie

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Display Devices for Diagnostic Radiology". This draft guidance document provides recommendations for the types of information you should provide in your premarket notification submission (510(k)) for display devices intended for diagnostic radiology with the assigned product code PGY. This guidance, when finalized, will replace a previously issued final guidance entitled "Display Accessories for Full-Field Digital Mammography Systems-Premarket Notification (510(k)) Submissions," issued on May 30, 2008. This draft guidance is not final nor is it in effect at this time.