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 2018_register executive 2018-06-07 article Notices D09002ee1c7e65a49 D09002ee1c7e65bba 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 Agency) is announcing the availability of a draft document entitled "Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program; Draft Guidance for Industry and Food and Drug Administration Staff." This draft guidance document provides an overview of the mechanisms available to applicants through which they can request feedback from or a meeting with FDA regarding potential or planned medical device investigational device exemption (IDE) applications, premarket approval (PMA) applications, humanitarian device exemption (HDE) applications, evaluation of automatic class III designations (de novo requests), premarket notification (510(k)) submissions, Clinical Laboratory Improvement Amendments (CLIA) Waiver by Application, Accessory Classification Requests, and certain investigational new drug (IND) applications and biologics license applications (BLAs). This draft guidance, when finalized, is intended to supersede the document entitled "Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff" issued on September 29, 2017. This draft guidance is not final nor is it in effect at this time. 83 FR 26482 https://www.govinfo.gov/app/details/FR-2018-06-07/2018-12223 2018-12223 fr07jn18-66 4164-01-P Docket No. FDA-2018-D-1774 https://www.govinfo.gov/app/details/FR-2018-06-07/2018-12223 https://www.govinfo.gov/content/pkg/FR-2018-06-07/html/2018-12223.htm https://www.govinfo.gov/content/pkg/FR-2018-06-07/pdf/2018-12223.pdf 2 p. 26482 26483 83 FR 26482 Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Federal Register Vol. 83, Issue NOTICE 2018-12223 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2018-08-06 Docket No. FDA-2018-D-1774 4164-01-P 2018-12223 Notice of availability.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled "Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program; Draft Guidance for Industry and Food and Drug Administration Staff." This draft guidance document provides an overview of the mechanisms available to applicants through which they can request feedback from or a meeting with FDA regarding potential or planned medical device investigational device exemption (IDE) applications, premarket approval (PMA) applications, humanitarian device exemption (HDE) applications, evaluation of automatic class III designations (de novo requests), premarket notification (510(k)) submissions, Clinical Laboratory Improvement Amendments (CLIA) Waiver by Application, Accessory Classification Requests, and certain investigational new drug (IND) applications and biologics license applications (BLAs). This draft guidance, when finalized, is intended to supersede the document entitled "Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff" issued on September 29, 2017. This draft guidance is not final nor is it in effect at this time.

Submit either electronic or written comments on the draft guidance by August 6, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. J. Allen Hill, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5627, Silver Spring, MD 20993-0002, 301-796-7086; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240-402-7911. Guidance: Requests for Feedback and Meetings for Medical Device Submissions: QSubmission Program , CDRH-Guidance@fda.hhs.gov https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf https://www.regulations.gov Vol. 83, no. 110 Office of the Federal Register, National Archives and Records Administration 2018-06-07 continuing daily deposited born digital 210 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2018-06-07 P0b002ee19ad8aa64 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr07jn18 https://www.govinfo.gov/app/details/FR-2018-06-07 https://www.govinfo.gov/content/pkg/FR-2018-06-07/pdf/FR-2018-06-07.pdf https://www.govinfo.gov/content/pkg/FR-2018-06-07/xml/FR-2018-06-07.xml fdlp 26347 26546 DGPO 2018-06-07 2024-06-01 FR-2018-06-07 machine generated eng FR FR-2018-06-07 83 110