Discrepancies Between Clearance Summaries and Marketing Materials of Software-Enabled Medical Devices Cleared by the US Food and Drug Administration

JAMA Netw Open. 2023 Jul 3;6(7):e2321753. doi: 10.1001/jamanetworkopen.2023.21753.

Authors

Nigam H Shah^{1

2}, Michelle M Mello³

Affiliations

¹ Clinical Excellence Research Center, Department of Medicine, Stanford University, Stanford, California.
² Technology and Digital Solutions, Stanford Healthcare, Palo Alto, California.
³ Department of Health Research and Policy, Stanford Law School and Stanford School of Medicine, Stanford, California.

PMID: 37405777
DOI: 10.1001/jamanetworkopen.2023.21753

No abstract available

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MeSH terms

Humans
Marketing*
Software*
United States
United States Food and Drug Administration