federal_register: 2022-26729

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2022-26729 Voluntary Malfunction Summary Reporting Program for Manufacturers; Draft Guidance for Industry and Food and Drug Administration Staff; Availability Notice The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers." We are publishing this notice of availability for this draft guidance document to help manufacturers better understand and use the VMSR Program. It is intended to further explain, but not change, the conditions of the VMSR Program. This draft guidance is not final nor is it for implementation at this time. 2022-12-09 2022 12 https://www.federalregister.gov/documents/2022/12/09/2022-26729/voluntary-malfunction-summary-reporting-program-for-manufacturers-draft-guidance-for-industry-and https://www.govinfo.gov/content/pkg/FR-2022-12-09/pdf/2022-26729.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and Drug Administration 221,199 The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers." We are publishing this notice of availability for this draft...

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