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FDA Regulation and Approval of Medical Devices: 1976-2020

Educational Objective
To review the regulation of medical devices by the US Food and Drug Administration (FDA).
1 Credit CME
Key Points

Question  How has regulation of medical devices evolved since the Medical Device Amendments of 1976 expanded the regulatory authority of the US Food and Drug Administration (FDA) over such products?

Findings  Medical device regulation has become more complex over time with the creation of new laws, manufacturer obligations, and FDA review pathways, along with an increase in industry funding of FDA device regulation.

Meaning  As medical devices have become more complex over the last 45 years, their oversight by the FDA has evolved as well, integrating regulatory changes such as expedited pathways and user fee funding.

Abstract

Importance  US law generally requires testing of high-risk medical devices prior to approval, as well as premarket evaluation of moderate-risk medical devices, with the goal of ensuring that the benefits of these products exceed their risks. The US Food and Drug Administration (FDA) attempts to balance the need for evidence generation with an approval process that facilitates access and encourages innovation.

Objective  To review the development of laws and standards affecting the evaluation and oversight of medical devices by the US regulatory system and the outcomes of this system from 1976 to 2020.

Evidence Review  Laws enacted by US Congress and regulations promulgated by the FDA through 2020; databases maintained by the FDA of device authorizations from 1976 to 2020; and annual reports of user fees paid to the FDA by industry.

Findings  Since Congress and the FDA initiated premarket review of medical devices in 1976, some fundamental innovations in the device regulation system have included special pathways to accelerate availability of investigational devices, more flexible evidence and review requirements, and increased funding to the FDA through industry-paid user fees. From 1987 to 2020, the annual number of novel devices granted premarket approval (which excludes supplements) ranged from 8 to 56 (median, 32), and the number of clearances for 510(k) devices (those that are “substantially equivalent” to marketed devices) ranged from 2804 to 5762 (median, 3404). User fee funding for devices was established in 2002 and annual fees collected increased from $30 million in 2003 (in 2019 dollars) to more than $208 million in 2019; this represented 43% of FDA funding related to the review of medical devices. Although many new devices have led to considerable patient benefit, such as hypodermic needles and magnetic resonance imaging machines, important adverse events caused by some devices, such as an implanted device for birth control and a surgical mesh implant for pelvic organ prolapse, have led to calls to reexamine the regulatory system for such products.

Conclusions and Relevance  Over the last 45 years, medical device regulation has become more complex, with more regulatory pathways and greater variations in the evidence and controls required for authorization. Increased FDA support from industry and concern about flexible authorization requirements reflect the tension between efficient access and the need for assurances that products will safely benefit patients.

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Article Information

Corresponding Author: Jonathan J. Darrow, SJD, LLM, JD, MBA, Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, 1620 Tremont St, Ste 3030, Boston, MA 02120 (jjdarrow@bwh.harvard.edu).

Accepted for Publication: June 28, 2021.

Author Contributions: Dr Darrow had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: All authors.

Acquisition, analysis, or interpretation of data: Darrow, Kesselheim.

Drafting of the manuscript: Darrow.

Critical revision of the manuscript for important intellectual content: All authors.

Statistical analysis: Darrow.

Obtained funding: Kesselheim.

Administrative, technical, or material support: Avorn.

Supervision: All authors.

Conflict of Interest Disclosures: Dr Darrow reported receiving grants from the Commonwealth Fund, the Greenwall Foundation, the Kaiser Permanente Institute for Health Policy, West Health, and under a Novo Nordisk Foundation grant for a scientifically independent Collaborative Research Programme (grant NNF17SA0027784) during the conduct of the study. No other disclosures were reported.

Funding/Support: This study was supported by Arnold Ventures.

Role of the Funder/Sponsor: The funder had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Additional Contributions: We thank Erika Lietzan, JD, University of Missouri–Columbia, Sanket Dhruva, MD, University of California–San Francisco, and Diana Zuckerman, PhD, National Center for Health Research, for helpful comments on the completed draft. They received no compensation for their help.

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