Subjects: Software -- standards - Digital Collections - National Library of Medicine Search Results

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NLM Digital Collections

Start Over Subjects Software -- standards

1. Content of premarket submissions for device software functions: guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, June 14, 2023
Subject(s):: Device Approval
Government Regulation
Software -- legislation & jurisprudence
Software -- standards
Software Design
United States

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

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, October 25, 2017
Subject(s):: Device Approval -- standards
Software -- standards
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

3. Software as a medical device (SAMD): clinical evaluation : guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, December 8, 2017
Subject(s):: Equipment and Supplies -- standards
Reproducibility of Results
Software -- standards
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration