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. 2016 Jun 27;1(4):277-287.
doi: 10.1016/j.jacbts.2016.03.009. eCollection 2016 Jun.

Drugs, Devices, and the FDA: Part 2: An Overview of Approval Processes: FDA Approval of Medical Devices

Gail A Van Norman  1
Affiliations

Drugs, Devices, and the FDA: Part 2: An Overview of Approval Processes: FDA Approval of Medical Devices

Gail A Van Norman. JACC Basic Transl Sci. .

Abstract

As with new drugs, the U.S. Food and Drug Administration's approval process is intended to provide consumers with assurance that, once it reaches the market place, a medical device is safe and effective in its intended use. Bringing a device to market takes an average of 3 to 7 years, compared with an average of 12 years for drugs. However, there are concerns that Food and Drug Administration processes may not be sufficient to meet the assurances of safety and efficacy as intended. This second part of a 2-part series reviews the basic steps in development and Food and Drug Administration approval of medical devices, and summarizes post-marketing processes for drugs and devices.

Keywords: CDRH, Center for Devices and Radiological Health; FDA, Food and Drug Administration; Food and Drug Administration; HDE, humanitarian device exemption; HUD, humanitarian use device; IDE, investigational device exemption; IRB, institutional review board; PMA, pre-market approval; PMN, pre-market notification; eCopy, electronic copy; humanitarian device exemption; medical device; post-market surveillance; pre-market approval; pre-market notification.

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Figures

Central Illustration
Central Illustration
FDA Medical Device Approval Pathways* *Early consultation with Food and Drug Administration (FDA) through pre-submission meetings in strongly encouraged; the FDA can help determine which pathway and applications are needed, as well as determine whether clinical trials are necessary. FFDCA = Federal Food, Drug, and Cosmetics Act; HDE = human device exemption; IDE = investigational device exemption; IRB = Institutional Review Board; PMA = pre-market approval; PMN = pre-market notification.
Figure 1
Figure 1
Similar Processes in Drug and Device Approval HDE = human device exemption; IDE = investigational device exemption; IND = investigational new drug; PMA = pre-market approval.
See this image and copyright information in PMC

References

    1. U.S. Food and Drug Administration. History. Available at: http://www.fda.gov/AboutFDA/WhatWeDo/History/default.htm. Accessed March 4, 2016.
    1. Federal Food Drug and Cosmetics Act P.L. 75-717, 1938, §505(c) and (d).
    1. Fargen K.M., Frei D., Fiorella D. The FDA approval process for medical devices: an inherently flawed system or a valuable pathway for innovation? J Neurointerv Surg. 2013;5:269–275. - PubMed
    1. Federal Food Drug and Cosmetics Act 21 U.S.C. 321(h).
    1. U.S. Food and Drug Administration. Classification of Products as Drugs and Devices and Additional Product Classification Issues. Available at: http://www.fda.gov/RegulatoryInformation/Guidances/ucm258946.htm. Accessed March 4, 2016.

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