Deciding when to submit a 510(k) for a software change to an existing device: guidance for industry and Food and Drug Administration staff Deciding when to submit a 510(k) for a software change to an existing device: guidance for industry and Food and Drug Administration staff

Collection: Health Policy and Services Research Series Title(s): Guidance for industry Contributor(s): United States. Department of Health and Human Services, issuing body. United States. Food and Drug Administration, issuing body. Center for Biologics Evaluation and Research (U.S.), issuing body. Center for Devices and Radiological Health (U.S.), issuing body. Publication: Silver Spring, MD : Center for Devices and Radiological Health, October 25, 2017 Language(s): English Format: Text Subject(s): Device Approval -- standards Software -- standards United States United States. Department of Health and Human Services United States. Food and Drug Administration Genre(s): Guideline Technical Report Copyright: The National Library of Medicine believes this item to be in the public domain. (More information) Extent: 1 online resource (1 PDF file (28 pages)). NLM Unique ID: 101719885 (See catalog record) Permanent Link: http://resource.nlm.nih.gov/101719885