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 2018-03-21 article Proposed Rules D09002ee1c7ea339f D09002ee1c7ea34b4 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Government Agency or Subagency The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry and FDA staff entitled "Postmarketing Safety Reporting for Combination Products." This draft guidance addresses certain means by which applicants may comply with the final rule on postmarketing safety reporting (PMSR) requirements for combination products that FDA issued on December 20, 2016. Combination products are products composed of two or more different types of medical products (drug, device, and/or biological product). Although the PMSR regulations for drugs, devices, and biological products share many similarities, each set of regulations establishes distinct postmarketing reporting requirements, standards, and timeframes. The final rule provides clarity on the PMSR requirements for combination products to ensure consistent and complete reporting while avoiding duplication. This draft guidance is not final nor is it in effect at this time. 83 FR 12292 https://www.govinfo.gov/app/details/FR-2018-03-21/2018-05687 2018-05687 fr21mr18-21 4164-01-P Docket No. FDA-2008-N-0424 https://www.govinfo.gov/app/details/FR-2018-03-21/2018-05687 https://www.govinfo.gov/content/pkg/FR-2018-03-21/html/2018-05687.htm https://www.govinfo.gov/content/pkg/FR-2018-03-21/pdf/2018-05687.pdf 3 p. 12292 12294 83 FR 12292 Title 21 Part 4 21 CFR Part 4 Postmarketing Safety Reporting for Combination Products; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Federal Register Vol. 83, Issue PRORULE 2018-05687 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2018-06-19 Docket No. FDA-2008-N-0424 4164-01-P 2018-05687 Notification of availability.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry and FDA staff entitled "Postmarketing Safety Reporting for Combination Products." This draft guidance addresses certain means by which applicants may comply with the final rule on postmarketing safety reporting (PMSR) requirements for combination products that FDA issued on December 20, 2016. Combination products are products composed of two or more different types of medical products (drug, device, and/or biological product). Although the PMSR regulations for drugs, devices, and biological products share many similarities, each set of regulations establishes distinct postmarketing reporting requirements, standards, and timeframes. The final rule provides clarity on the PMSR requirements for combination products to ensure consistent and complete reporting while avoiding duplication. 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 June 19, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. Melissa Burns, Office of Combination Products, Food and Drug Administration, 301-796-5616, melissa.burns@fda.hhs.gov. Guidance: Postmarketing Safety Reporting for Combination Products , melissa.burns@fda.hhs.gov https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm109110.htm https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf https://www.regulations.gov Vol. 83, no. 55 Office of the Federal Register, National Archives and Records Administration 2018-03-21 continuing daily deposited born digital 237 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2018-03-21 P0b002ee199bcd0de 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr21mr18 https://www.govinfo.gov/app/details/FR-2018-03-21 https://www.govinfo.gov/content/pkg/FR-2018-03-21/pdf/FR-2018-03-21.pdf https://www.govinfo.gov/content/pkg/FR-2018-03-21/xml/FR-2018-03-21.xml fdlp 12243 12470 DGPO 2018-03-21 2024-06-01 FR-2018-03-21 machine generated eng FR FR-2018-03-21 83 55