United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2022_register executive 2022-01-13 article Rules and Regulations D09002ee1c7aa453f D09002ee1c7aa467a United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend the medical device regulations regarding the procedures for the announcement of approvals and denials of premarket approval applications (PMAs) and humanitarian device exemption applications (HDEs). This final rule discontinues the publication in the Federal Register after each quarter of a list of PMA and HDE approvals and denials announced in that quarter. We will continue to post approval and denial notices for PMAs and HDEs on FDA's home page on the internet and will also continue to make available on the internet and place on public display summaries of safety and effectiveness data (SSED) for PMAs and summaries of safety and probable benefit (SSPB) for HDEs. FDA is taking this action to improve the efficiency of announcing approvals and denials of PMAs and HDEs and to eliminate duplication in the current process for announcing this information. We are also updating Agency contact information and statutory references in certain sections of the PMA and HDE regulations for purposes of accuracy, clarity, and consistency. 87 FR 2042 https://www.govinfo.gov/app/details/FR-2022-01-13/2022-00501 2022-00501 fr13ja22-7 RIN 0910-AI10 4164-01-P Docket No. FDA-2019-N-3101 https://www.govinfo.gov/app/details/FR-2022-01-13/2022-00501 https://www.govinfo.gov/content/pkg/FR-2022-01-13/html/2022-00501.htm https://www.govinfo.gov/content/pkg/FR-2022-01-13/pdf/2022-00501.pdf Administrative Practice and Procedure Confidential Business Information Medical Devices Medical Research Reporting and Recordkeeping Requirements 4 p. 2042 2045 87 FR 2042 Title 21 Part 814 21 CFR Part 814 RIN 0910-AI10 Revised Procedures for the Announcement of Approvals and Denials of Premarket Approval Applications and Humanitarian Device Exemption Applications; Federal Register Vol. 87, Issue RULE 2022-00501 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2022-02-14 Docket No. FDA-2019-N-3101 4164-01-P 2022-00501 Final rule.

The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend the medical device regulations regarding the procedures for the announcement of approvals and denials of premarket approval applications (PMAs) and humanitarian device exemption applications (HDEs). This final rule discontinues the publication in the Federal Register after each quarter of a list of PMA and HDE approvals and denials announced in that quarter. We will continue to post approval and denial notices for PMAs and HDEs on FDA's home page on the internet and will also continue to make available on the internet and place on public display summaries of safety and effectiveness data (SSED) for PMAs and summaries of safety and probable benefit (SSPB) for HDEs. FDA is taking this action to improve the efficiency of announcing approvals and denials of PMAs and HDEs and to eliminate duplication in the current process for announcing this information. We are also updating Agency contact information and statutory references in certain sections of the PMA and HDE regulations for purposes of accuracy, clarity, and consistency.

This rule is effective February 14, 2022. For information concerning the final rule as it relates to devices regulated by the Center for Biologics Evaluation and Research: Tami Belouin, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911. Administrative Practice and Procedure Confidential Business Information Medical Devices Medical Research Reporting and Recordkeeping Requirements Procedures for the Announcement of Approvals and Denials of Premarket Approval Applications and Humanitarian Device Exemption Applications, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfhde/hde.cfm https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm https://www.fda.gov https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations https://www.fda.gov/vaccines-blood-biologics/approved-blood-products/premarket-approvals-and-humanitarian-device-exemptions-supporting-documents https://www.regulations.gov Vol. 87, no. 9 Office of the Federal Register, National Archives and Records Administration 2022-01-13 continuing daily deposited born digital 291 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2022-01-13 P0b002ee1b2f698ed 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr13ja22 https://www.govinfo.gov/app/details/FR-2022-01-13 https://www.govinfo.gov/content/pkg/FR-2022-01-13/pdf/FR-2022-01-13.pdf https://www.govinfo.gov/content/pkg/FR-2022-01-13/xml/FR-2022-01-13.xml fdlp 2027 2307 DGPO 2022-01-13 2024-05-29 FR-2022-01-13 machine generated eng FR FR-2022-01-13 87 9