federal_register: 2022-26767

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2022-26767 Content of Human Factors Information in Medical Device Marketing Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability Notice The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Content of Human Factors Information in Medical Device Marketing Submissions." This draft guidance provides a risk-based framework to guide manufacturers and FDA staff on the human factors information that should be included in a marketing submission to the Center for Devices and Radiological Health to facilitate the efficiency of the FDA review process. This draft guidance is not final nor is it for implementation at this time. 2022-12-09 2022 12 https://www.federalregister.gov/documents/2022/12/09/2022-26767/content-of-human-factors-information-in-medical-device-marketing-submissions-draft-guidance-for https://www.govinfo.gov/content/pkg/FR-2022-12-09/pdf/2022-26767.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and Drug Administration 221,199 The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Content of Human Factors Information in Medical Device Marketing Submissions." This draft guidance provides a risk-based framework to guide...

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