federal_register: 2023-12723

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
2023-12723 Content of Premarket Submissions for Device Software Functions; Guidance for Industry and Food and Drug Administration Staff; Availability Notice The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Content of Premarket Submissions for Device Software Functions." This guidance document is intended to provide information regarding the recommended documentation sponsors should include in premarket submissions for FDA's evaluation of safety and effectiveness of device software functions, which are functions that meet the definition of a device under the Federal Food, Drug, and Cosmetic Act (FD&C Act). This document replaces FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005, and updates FDA's thinking related to the documentation FDA recommends sponsors include for the review of device software functions in premarket submissions. 2023-06-14 2023 6 https://www.federalregister.gov/documents/2023/06/14/2023-12723/content-of-premarket-submissions-for-device-software-functions-guidance-for-industry-and-food-and https://www.govinfo.gov/content/pkg/FR-2023-06-14/pdf/2023-12723.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Content of Premarket Submissions for Device Software Functions." This guidance document is intended to provide information regarding the...  

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