FDA-SOFTWARE GUIDANC › Complete Document History
Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices

Complete Current Edition:
   2023 EDITION - Content of Premarket Submissions for Device Software Functions - June 14, 2023

Obsolete Revision Information:
   2005 EDITION - Guidance for the Content of Premarket Submissions for Softwa - May 11, 2005
   1998 EDITION - GUIDANCE FOR FDA REVIEWERS & I - May 29, 1998