Regulatory considerations for medical imaging AI/ML devices in the United States: concepts and challenges.

Petrick, Nicholas; Chen, Weijie; Delfino, Jana G; Gallas, Brandon D; Kang, Yanna; Krainak, Daniel; Sahiner, Berkman; Samala, Ravi K

Petrick, Nicholas; Chen, Weijie; Delfino, Jana G; Gallas, Brandon D; Kang, Yanna; Krainak, Daniel; Sahiner, Berkman; Samala, Ravi K.

Afiliação

Petrick N; U.S. Food and Drug Administration, Center for Devices and Radiological Health, Office of Science and Engineering Labs, Silver Spring, Maryland, United States.
Chen W; U.S. Food and Drug Administration, Center for Devices and Radiological Health, Office of Science and Engineering Labs, Silver Spring, Maryland, United States.
Delfino JG; U.S. Food and Drug Administration, Center for Devices and Radiological Health, Office of Science and Engineering Labs, Silver Spring, Maryland, United States.
Gallas BD; U.S. Food and Drug Administration, Center for Devices and Radiological Health, Office of Science and Engineering Labs, Silver Spring, Maryland, United States.
Kang Y; U.S. Food and Drug Administration, Center for Devices and Radiological Health, Office of Product Evaluation and Quality, Silver Spring, Maryland, United States.
Krainak D; U.S. Food and Drug Administration, Center for Devices and Radiological Health, Office of Product Evaluation and Quality, Silver Spring, Maryland, United States.
Sahiner B; U.S. Food and Drug Administration, Center for Devices and Radiological Health, Office of Science and Engineering Labs, Silver Spring, Maryland, United States.
Samala RK; U.S. Food and Drug Administration, Center for Devices and Radiological Health, Office of Science and Engineering Labs, Silver Spring, Maryland, United States.

J Med Imaging (Bellingham) ; 10(5): 051804, 2023 Sep.

Article em En | MEDLINE | ID: mdl-37361549

Palavras-chave

AI/ML; assessment methods; medical imaging; regulatory concepts; regulatory science

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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Tipo de estudo: Guideline / Prognostic_studies Idioma: En Revista: J Med Imaging (Bellingham) Ano de publicação: 2023 Tipo de documento: Article País de afiliação: Estados Unidos

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