Breakthrough Medical Devices and the 21st Century Cures Act

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Ideas and Opinions5 April 2016Breakthrough Medical Devices and the 21st Century Cures ActAaron S. Kesselheim, MD, JD, MPH and Thomas J. Hwang, ABAaron S. Kesselheim, MD, JD, MPHFrom Brigham and Women's Hospital and Harvard Medical School and Bain Capital Ventures, Boston, Massachusetts. and Thomas J. Hwang, ABFrom Brigham and Women's Hospital and Harvard Medical School and Bain Capital Ventures, Boston, Massachusetts.Author, Article, and Disclosure Informationhttps://doi.org/10.7326/M15-1906 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail Accelerating the U.S. Food and Drug Administration's (FDA's) development and approval of medical devices has emerged as a bipartisan policymaking priority. In July 2015, the House of Representatives overwhelmingly passed the 21st Century Cures Act, which includes a provision for an expedited regulatory review program for "breakthrough" devices. The Senate has not yet introduced its own version of this act. We believe that important lessons for this program can be learned from the experience of a sister program that designates certain new drugs as breakthrough therapies.The FDA currently approves high-risk devices (such as implantable pacemakers) through the premarket approval ...References1. 21 C.F.R. § 814.100 (2015). Google Scholar2. Gartenberg AJ, Peleg A, Dhruva SS, Redberg RF. Presumed safe no more: lessons from the Wingspan saga on regulation of devices. BMJ. 2014;348:g93. [PMID: 24452627] doi:10.1136/bmj.g93 CrossrefMedlineGoogle Scholar3. U.S. Food and Drug Administration. Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions: Guidance for Industry and Food and Drug Administration Staff. Silver Spring, MD: U.S. Food and Drug Administration; 2015. 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Outpatient glycemic control with a bionic pancreas in type 1 diabetes. N Engl J Med. 2014;371:313-25. [PMID: 24931572] doi:10.1056/NEJMoa1314474 CrossrefMedlineGoogle Scholar8. Reynolds IS, Rising JP, Coukell AJ, Paulson KH, Redberg RF. Assessing the safety and effectiveness of devices after US Food and Drug Administration approval: FDA-mandated postapproval studies. JAMA Intern Med. 2014;174:1773-9. [PMID: 25265209] doi:10.1001/jamainternmed.2014.4194 CrossrefMedlineGoogle Scholar9. Hwang TJ, Carpenter D, Kesselheim AS. Assessment of US pathway for approving medical devices for rare conditions. BMJ. 2014;348:g217. [PMID: 24443478] doi:10.1136/bmj.g217 CrossrefMedlineGoogle Scholar Author, Article, and Disclosure InformationAffiliations: From Brigham and Women's Hospital and Harvard Medical School and Bain Capital Ventures, Boston, Massachusetts.Disclaimer: The views expressed in this article are solely those of the authors.Acknowledgment: The authors thank Ameet Sarpatwari, JD, PhD, for his comments on an earlier draft.Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M15-1906.Corresponding Author: Aaron S. Kesselheim, MD, JD, MPH, Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, 1620 Tremont Street, Suite 3030, Boston, MA 02120; e-mail, [email protected]org.Current Author Addresses: Dr. Kesselheim: Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, 1620 Tremont Street, Suite 3030, Boston, MA 02120.Mr. Hwang: Bain Capital Ventures, 200 Clarendon Street, Boston, MA 02116.Author Contributions: Conception and design: A.S. Kesselheim, T.J. Hwang.Analysis and interpretation of the data: T.J. Hwang.Drafting of the article: A.S. Kesselheim, T.J. Hwang.Critical revision of the article for important intellectual content: A.S. Kesselheim, T.J. Hwang.Final approval of the article: A.S. Kesselheim, T.J. Hwang.Provision of study materials or patients: T.J. Hwang.Collection and assembly of data: T.J. Hwang.This article was published online first at www.annals.org on 19 January 2016. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetails Metrics Cited byExperts' Views on FDA Regulatory Standards for Drug and High-Risk Medical Devices: Implications for Patient CareStrategies to Manage Drugs and Devices Approved Based on Limited Evidence: Results of a Modified Delphi PanelThe Ethics of Emergent Health Technologies: Implications of the 21st Century Cures Act for NursingGenerating comparative evidence on new drugs and devices before approvalElectrophysiology devices and the regulatory approval process within the U.S. FDA and abroadReal-World Data on Heart Failure Readmission ReductionReview times and adverse events for cardiovascular devices 5 April 2016Volume 164, Issue 7Page: 500-502KeywordsDrug marketingDrug therapyDrugsFood and Drug AdministrationHospital medicineInsulinPharmacoeconomicsPharmacoepidemiologyPhase 2 trialsSafety ePublished: 19 January 2016 Issue Published: 5 April 2016 Copyright & PermissionsCopyright © 2016 by American College of Physicians. 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