Premarket Approval Supplement Pathway: Do We Know What We Are Getting?
Authors: Sarah Y. Zheng, Rita F. Redberg
Journal: Annals of Internal Medicine (2014)

Ideas and Opinions3 June 2014Premarket Approval Supplement Pathway: Do We Know What We Are Getting?Sarah Y. Zheng, AB and Rita F. Redberg, MDSarah Y. Zheng, ABFrom University of California, San Francisco, San Francisco, California. and Rita F. Redberg, MDFrom University of California, San Francisco, San Francisco, California.Author, Article, and Disclosure Informationhttps://doi.org/10.7326/M13-2931 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail The global medical device industry has dramatically expanded in the past 5 years, with the market expected to be valued at more than $228 billion by 2015 as medical devices increase in number, use, and complexity (1). High-risk (class III) devices (those that "support or sustain human life" [2]) are generally approved by the U.S. Food and Drug Administration (FDA) via a pathway known as "premarket approval" (PMA), which uses criteria of safety and effectiveness. However, modifications of PMA devices may be approved by a less rigorous procedure known as "PMA supplement," which has substantially fewer evidence requirements than an ...References1. MarketsandMarkets. Global Top 10 Medical Devices Market (2010–2015). Report MD 1620. Pune, India: MarketsandMarkets; 2011. Google Scholar2. U.S. Food and Drug Administration. Premarket Approval (PMA). Silver Spring, MD: U.S. Food and Drug Administration; 2012. Accessed at www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmissions/premarketapprovalpma on 3 September 2013. Google Scholar3. U.S. Food and Drug Administration. PMA Supplements and Amendments. Silver Spring, MD: U.S. Food and Drug Administration; 2010. Accessed at www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketApprovalPMA/ucm050467.htm on 3 September 2013. Google Scholar4. Hauser RG, Hayes DL. Increasing hazard of Sprint Fidelis implantable cardioverter-defibrillator lead failure. Heart Rhythm. 2009;6:605-10. [PMID: 19285920] CrossrefMedlineGoogle Scholar5. Maisel WH. Semper fidelis—consumer protection for patients with implanted medical devices. N Engl J Med. 2008;358:985-7. [PMID: 18322280] CrossrefMedlineGoogle Scholar6. Maytin M, Love CJ, Fischer A, Carrillo RG, Garisto JD, Bongiorni MG, et al. Multicenter experience with extraction of the Sprint Fidelis implantable cardioverter-defibrillator lead. J Am Coll Cardiol. 2010;56:646-50. [PMID: 20598467] CrossrefMedlineGoogle Scholar7. Abdelhadi RH, Saba SF, Ellis CR, Mason PK, Kramer DB, Friedman PA, et al. Independent multicenter study of Riata and Riata ST implantable cardioverter-defibrillator leads. Heart Rhythm. 2013;10:361-5. [PMID: 23128017] CrossrefMedlineGoogle Scholar Author, Article, and Disclosure InformationAuthors: Sarah Y. Zheng, AB; Rita F. Redberg, MDAffiliations: From University of California, San Francisco, San Francisco, California.Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M13-2931.Corresponding Author: Rita F. Redberg, MD, University of California, San Francisco, 505 Parnassus Avenue, San Francisco, CA 94143-0124.Current Author Addresses: Ms. Zheng and Dr. Redberg: University of California, San Francisco, 505 Parnassus Avenue, San Francisco, CA 94143-0124.Author Contributions: Conception and design: S.Y. Zheng, R.F. Redberg.Analysis and interpretation of the data: S.Y. Zheng.Drafting of the article: S.Y. Zheng.Critical revision of the article for important intellectual content: R.F. Redberg.Final approval of the article: R.F. Redberg.Administrative, technical, or logistic support: R.F. Redberg.Collection and assembly of data: S.Y. Zheng, R.F. Redberg.This article was published online first at www.annals.org on 25 March 2014. 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