Guidance for the Content of Premark Submissions for Software Contained in Medical Devices关于医疗器械中软件预标记内容的指导.pdfVIP

Guidance for Industry and FDA Staff Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document issued on: May 11, 2005 This document supersedes Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, issued May 29, 1998, and Reviewer Guidance for a Premarket Notification Submission for Blood Establishment Computer Software, issued January 13, 1997. For questions regarding this document concerning devices regulated by CDRH contact Linda Shoemaker at (240) 276-4055. For questions regarding this document concerning devices regulated by CBER contact Linda Weir at (301) 827-6136. U.S. Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health Office of Device Evaluation Office of In Vitro Diagnostics Center for Biologics Evaluation and Research Office of Blood Research and Review Contains Nonbinding Recommendations Preface Public Comment Comments and suggestions may be submitted at any time for Agency consideration to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA- 305), Rockville, MD, 20852. When submitting comments, please refer to the exact title of this guidance document. Comments may not be acted upon by the Agency until the document is next revised or updated. Additional Copies CDRH Additional copies are available from the Internet at:/cdrh/ode/guidance/337.pdf, or to