Review of U.S. Medical Device Regulation

[+] Author and Article Information
Jan B. Pietzsch

Department of Management Science and Engineering, Stanford University, 380 Panama Way, Stanford, CA 94305-4026; Wing Tech Inc., 9916 Newhall Road, Potomac, MD 20854

Lauren M. Aquino, M. Elisabeth Paté-Cornell

Department of Management Science and Engineering, Stanford University, 380 Panama Way, Stanford, CA 94305-4026

Paul G. Yock, John H. Linehan

Department of Bioengineering, Stanford University, James H. Clark Center, 318 Campus Drive, E-100, Stanford, CA 94305-5428

Endosseous implants are implants that are placed in a hole drilled in the bone and are then allowed to gradually integrate over time.

Special controls could, for example, be guidance documents or specific published performance standards for a certain category of device that need to be followed by the manufacturer.

Significant risk device is an investigational device that (1) is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject; (2) is for use in supporting or sustaining human life and represents a potential for serious risk to the health, safety, or welfare of a subject; (3) is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject; or (4) otherwise presents a potential for serious risk to a subject.

Quality System: The organizational structure, responsibilities, procedures, processes, and resources for implementing quality management.

J. Med. Devices 1(4), 283-292 (Oct 19, 2007) (10 pages) doi:10.1115/1.2812429 History: Received March 14, 2007; Revised October 19, 2007

Medical device regulation plays a significant role in the design, development, and commercialization of new medical technologies. A comprehensive understanding of the various regulatory requirements and their practical implementation is thus an essential cornerstone of successful medical device innovation. In this paper, we review the background, mission, and statutory requirements of medical device regulation in the United States. As opposed to pharmaceuticals, which have been regulated since the early 1900s, medical device regulation was not enacted before 1976, when Congress signed into law the Medical Device Amendments to the Federal Food, Drug and Cosmetic Act of 1938. The U.S. Food and Drug Administration (FDA) has implemented a risk-based classification system, which is essential in determining the regulatory pathway for a given device. Our review of the different regulatory pathways discusses the specific steps and requirements associated with each pathway, and their implications for development and testing of different types of devices. The differences in these pathways are significant, and thus require careful consideration and analysis already at early stages of development. The FDA’s Quality Systems Regulation, which outlines specific requirements for development, testing, production, and postmarket surveillance, is another important aspect of device regulation. We present its elements and relationship to design controls and other operating procedures implemented by device manufacturers, and discuss their relevance in ensuring the safety and effectiveness of marketed devices. A summary of recent additions to device regulation, implemented by the FDA to allow for adequate regulation of products that combine drugs and devices or biologics and devices (so-called combination products), completes our review. Because of the significance of device regulation for medical device innovation, we strongly support increased efforts to educate the various stakeholders involved in the medical device development process, both at the academic and professional level.

Copyright © 2007 by American Society of Mechanical Engineers
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Grahic Jump Location
Figure 1

Distribution of regulatory classes and pathways of medical devices entering the United States market in 2003 (source: FDA data)

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Figure 2

Decision process for determination of substantial equivalence

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Figure 3

Components of CDRH Postmarket Program (20)




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