Focusing on burdensome regulatory issues and the imposition of a new medical device tax under the health care reform law, Congress has begun to examine specific changes to medical device regulations in the United States. As this debate unfolds, there is a clear opportunity for medical device manufacturers to engage actively in the legislative modifications that may emerge from this congressional oversight.

Recent Committee Activity

On Thursday, February 17, 2011, the Subcommittee on Health (the Subcommittee) of the House Committee on Energy and Commerce (the Committee) met to examine the impact of medical device regulations on jobs and patients. Members heard testimony from Jeffrey E. Shuren, M.D., J.D., Director of the Center for Devices and Radiological Health of the Food and Drug Administration (FDA), as well as several representatives from academia and the private sector.

As anticipated, in their opening statements and during their questioning of the witnesses, Republicans and Democrats on the Subcommittee expressed disparate points of view on the effect of regulations on the medical device industry. Republicans on the Subcommittee criticized the handling by the FDA of medical device approvals, stating that the slow and unreliable process in the United States has encouraged device manufacturers to shift their marketing focus overseas, thereby hurting American jobs.

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