The Medical Device Approval Process and Related Legislative Issues

Erin D. Williams
Specialist in Public Health and Bioethics

The central medical device issue for Congress is how best to help speed medical devices to consumers if they are safe and effective, and correct them or keep them from consumers if they are not. A medical device may be anything from a tongue depressor to a pacemaker. In order to be legally marketed in the United States, medical devices must be approved by the Food and Drug Administration (FDA), the agency responsible for protecting the public health by assuring the safety, efficacy, and security of human medical devices and other products. FDA's Center for Devices and Radiological Health (CDRH) is primarily responsible for medical device review. The regulation of medical devices can affect their cost, quality, and availability in the health care system. 

During reviews, FDA classifies devices according to the risk they pose to consumers. If a premarket review is warranted by the potential risk, a manufacturer must demonstrate that its device is safe and effective, or substantially equivalent to a device already on the market. FDA requires product manufacturers to register their facilities, list their devices with FDA, and follow general controls requirements. Manufacturers of FDA-approved devices are required to report serious adverse events associated with the use of their devices to FDA. In addition, tracking is required for some medical devices. 

The medical device approval process is currently funded through direct FDA appropriations from Congress, and increasingly through user fees collected from applicants. FDA's authority to collect user fees, originally authorized in 2002 (P.L. 107-250), has been reauthorized in five-year increments. It will next expire on October 1, 2012, under the terms of the FDA Amendments Act of 2007 (P.L. 110-85). 

The new health reform law (the Patient Protection and Affordable Care Act; PPACA; P.L. 111- 148, as amended by the Health Care and Education Reconciliation Act of 2010; HCERA; P.L. 111-152) contains two provisions related to medical devices. The law requires medical device related taxes as a source of revenue for health reform, and medical device manufacturers, among others, to report gifts to physicians. 

Device-related topics addressed in legislation proposed in the 111th Congress include taxes (HCERA); gift reporting requirements (PPACA); a national medical device registry (H.R. 3962); liability and preemption, as highlighted by Riegel v. Medtronic and Wyeth v. Levine (S. 540/H.R. 1346, H.R. 1086, S. 45, and S. 1324); the 501(k) clearance and device approval processes (H.R. 1321/S. 391); importation and inspection (H.R. 759 and S. 882); advertising (S. 301/H.R. 3138 and H.R. 3261); use of unapproved devices (H.R. 3261); laboratory test (in vitro diagnostic, or IVD) regulation; (H.R. 1699 and H.R. 1452); issues specific to certain devices, situations, diseases, or conditions (S. 717, S. 819, H.R. 1878, S. 586/H.R. 1483, H.R. 1380, H.R. 1236, H.R. 1142, S. 422/H.R. 1032, H.R. 1021, H.R. 554, S. 332, S. 254/H.R. 574, S. 236, H.R. 463, S. 21, H.R. 2088, H.Res. 577, and S. 1746); and certain other issues (H.R. 1531/S. 1089, H.R. 1737, S. 1733, S. 1591/H.R. 3560, H.R. 2454/S. 2998, H.R. 3012, H.R. 3090, H.R. 3242, and H.R. 3932). 

This report contains the legislative history of medical device regulation, describes FDA's approval process for medical devices, and provides an overview of the medical device-related legislative issues facing Congress.


Date of Report: April 21, 2010
Number of Pages: 34
Order Number: RL32826
Price: $29.95

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