The Medical Device Approval Process and Related Legislative Issues

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).

A number of medical device-related topics are of interest to Members of the 111th Congress, and have prompted the introduction of legislation with pertinent provisions. Three such topics are included in major health reform bills: medical device-related taxes as a source of revenue for health reform (H.R. 3962 and S.Amdt. 2786 to H.R. 3590), a national medical device registry (H.R. 3962), and reporting requirements for gifts to physicians (H.R. 3962 and S.Amdt. 2786 to H.R. 3590).

Device-related topics addressed in other legislation include 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); the use of unapproved devices (H.R. 3261); the regulation of laboratory tests, which are also known as in vitro diagnostic products, or IVDs (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, and H.Res. 577); and certain other issues (H.R. 1531/S. 1089, H.R. 1737, S. 1733, S. 1591/H.R. 3560, H.R. 2454/S. 1733, H.R. 3012, H.R. 3090 and H.R. 3242).

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.

This report will be updated as events warrant.

Date of Report: December 14, 2009
Number of Pages: 30
Order Number: RL32826
Price: $29.95
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