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 2016_register executive 2019-02-22 article Rules and Regulations D09002ee1c7f31012 D09002ee1c7f310c1 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 issuing regulations to set forth postmarketing safety reporting requirements for combination products. Specifically, this final rule describes the postmarketing safety reporting requirements that apply when two or more different types of regulated medical products (drugs, devices, and/or biological products, which are referred to as "constituent parts" of a combination product) comprise a combination product and the combination product or its constituent parts have received FDA marketing authorization. The rule is intended to promote and protect the public health by setting forth the requirements for postmarketing safety reporting for these combination products, and is part of FDA's ongoing effort to ensure the consistency and appropriateness of the regulatory requirements for combination products. 81 FR 92603 https://www.govinfo.gov/app/details/FR-2016-12-20/2016-30485 2016-30485 fr20de16-8 RIN 0910-AF82 4164-01-P Docket No. FDA-2008-N-0424 https://www.govinfo.gov/app/details/FR-2016-12-20/2016-30485 https://www.govinfo.gov/content/pkg/FR-2016-12-20/html/2016-30485.htm https://www.govinfo.gov/content/pkg/FR-2016-12-20/pdf/2016-30485.pdf Biological Products Combination Products Drugs Medical Devices Regulation of Combination Products Reporting and Recordkeeping Requirements Safety 24 p. 92603 92626 81 FR 92603 Title 21 Part 4 21 CFR Part 4 RIN 0910-AF82 Postmarketing Safety Reporting for Combination Products; Federal Register Vol. 81, Issue RULE 2016-30485 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2017-01-19 Docket No. FDA-2008-N-0424 4164-01-P 2016-30485 Final rule.

The Food and Drug Administration (FDA or Agency) is issuing regulations to set forth postmarketing safety reporting requirements for combination products. Specifically, this final rule describes the postmarketing safety reporting requirements that apply when two or more different types of regulated medical products (drugs, devices, and/or biological products, which are referred to as "constituent parts" of a combination product) comprise a combination product and the combination product or its constituent parts have received FDA marketing authorization. The rule is intended to promote and protect the public health by setting forth the requirements for postmarketing safety reporting for these combination products, and is part of FDA's ongoing effort to ensure the consistency and appropriateness of the regulatory requirements for combination products.

Effective date: This rule is effective on January 19, 2017. John Barlow Weiner, Associate Director for Policy, Office of Combination Products, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5129, Silver Spring, MD 20933, 301-796-8930, john.weiner@fda.hhs.gov. Biological Products Combination Products Drugs Medical Devices Regulation of Combination Products Reporting and Recordkeeping Requirements Safety Postmarketing Safety Reporting for Combination Products , john.weiner@fda.hhs.gov http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm http://www.fda.gov/CombinationProducts/default.htm http://www.fda.gov/downloads/CombinationProducts/MeetingsConferencesWorkshops/UCM117123.pdf http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm359566.pdf http://www.fda.gov/ForIndustry/DataStandards/IndividualCaseSafetyReports/default.htm http://www.fda.gov/medicaldevices/deviceregulationandguidance/postmarketrequirements/recallscorrectionsandremovals/default.htm http://www.fda.gov/ohrms/dockets/dockets/03n0203/03n0203.htm http://www.regulations.gov Vol. 81, no. 244 Office of the Federal Register, National Archives and Records Administration 2016-12-20 continuing daily deposited born digital 1078 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2016-12-20 P0b002ee19f50ca0a 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr20de16 https://www.govinfo.gov/app/details/FR-2016-12-20 https://www.govinfo.gov/content/pkg/FR-2016-12-20/pdf/FR-2016-12-20.pdf https://www.govinfo.gov/content/pkg/FR-2016-12-20/xml/FR-2016-12-20.xml fdlp 92499 93569 DGPO 2019-02-22 2024-06-01 FR-2016-12-20 machine generated eng FR FR-2016-12-20 81 244