federal_register: 2023-06291
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
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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 |
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| 2023-06291 | Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency; Guidance for Industry, Other Stakeholders, 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 "Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency." FDA recognizes that it will take time for device manufacturers, device distributors, healthcare facilities, healthcare providers, patients, consumers, and FDA to adjust from policies adopted and operations implemented during the COVID-19 public health emergency (PHE) to "normal operations." To provide a clear policy for all stakeholders and FDA staff, the Agency is issuing this guidance to describe FDA's general recommendations for a phased transition process with respect to devices that fall within certain enforcement policies issued during the COVID-19 PHE declared by the Secretary of Health and Human Services (the Secretary) under the Public Health Service Act (PHS Act), including recommendations regarding submitting a marketing submission, as applicable, and taking other actions with respect to these devices. This guidance applies to devices that fall within enforcement policies in guidances included in List 1 of this guidance. The phased transition process outlined in this guidance will begin on the "implementation date." The implementation date is the day the PHE expires or 45 days after the finalization of this guidance, whichever comes later. Because the COVID-19 section 319 PHE declaration is anticipated to expire at least 45 days after the finalization of this guidance, or May 11, 2023, the implementation date is that date. The guidances in List 1 of this guidance will no longer be in effect after the 180-day transition period ends. | 2023-03-27 | 2023 | 3 | https://www.federalregister.gov/documents/2023/03/27/2023-06291/transition-plan-for-medical-devices-that-fall-within-enforcement-policies-issued-during-the | https://www.govinfo.gov/content/pkg/FR-2023-03-27/pdf/2023-06291.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 "Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health... |