Subjects: Software -- legislation & jurisprudence - Digital Collections - National Library of Medicine Search Results

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NLM Digital Collections

Start Over Subjects Software -- legislation & jurisprudence

1. Changes to existing medical software policies resulting from section 3060 of the 21st Century Cures Act: guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, September 27, 2019
Subject(s):: Equipment and Supplies -- standards
Software -- legislation & jurisprudence
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
United States.
United States.

2. 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