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 2022-01-28 article Notices D09002ee1c7a9b5e7 D09002ee1c7a9b7c4 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 or the Agency) is extending the comment period for the notice of availability that appeared in the Federal Register of December 23, 2021. In the notice of availability, FDA requested comments on draft guidance for industry and FDA staff entitled "Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions." The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments. 87 FR 4611 https://www.govinfo.gov/app/details/FR-2022-01-28/2022-01788 2022-01788 fr28ja22-82 4164-01-P Docket No. FDA-2021-D-0980 https://www.govinfo.gov/app/details/FR-2022-01-28/2022-01788 https://www.govinfo.gov/content/pkg/FR-2022-01-28/html/2022-01788.htm https://www.govinfo.gov/content/pkg/FR-2022-01-28/pdf/2022-01788.pdf 2 p. 4611 4612 87 FR 4611 Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Extension of Comment Period; Federal Register Vol. 87, Issue NOTICE 2022-01788 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2022-03-24 Docket No. FDA-2021-D-0980 4164-01-P 2022-01788 Notice of availability; extension of comment period.

The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice of availability that appeared in the Federal Register of December 23, 2021. In the notice of availability, FDA requested comments on draft guidance for industry and FDA staff entitled "Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions." The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.

FDA is extending the comment period on the document published December 23, 2021 (86 FR 72969). Submit either electronic or written comments on the draft guidance by March 24, 2022, to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. Pras Pathmanathan, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1133, Silver Spring, MD 20993-0002, 301- 796-3490. Guidance: Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions, CDRH-Guidance@fda.hhs.gov https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products https://www.fda.gov/regulatory-information/search-fda-guidance-documents https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf https://www.regulations.gov Vol. 87, no. 19 Office of the Federal Register, National Archives and Records Administration 2022-01-28 continuing daily deposited born digital 319 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2022-01-28 P0b002ee1b32e10fd 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr28ja22 https://www.govinfo.gov/app/details/FR-2022-01-28 https://www.govinfo.gov/content/pkg/FR-2022-01-28/pdf/FR-2022-01-28.pdf https://www.govinfo.gov/content/pkg/FR-2022-01-28/xml/FR-2022-01-28.xml fdlp 4455 4762 DGPO 2022-01-28 2024-05-29 FR-2022-01-28 machine generated eng FR FR-2022-01-28 87 19