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Loopholes in Approval Process for Medical Devices

  • Published: 2010-07-30 - Contact: Knapp & Roberts
  • Synopsis: From food to cosmetics to prescription drugs to vaccines, Americans rely on the FDA to keep the products we use safe.

Main Document

A recent report by Public Citizen, an advocacy group based in Washington, D.C., highlights what it refers to as "significant loopholes" in the approval process for medical devices.

The U.S. Food and Drug Administration is responsible for regulating many of the products we encounter in everyday life. From food to cosmetics to prescription drugs to vaccines, Americans rely on the FDA to keep the products we use safe.

The FDA is also responsible for approving and regulating medical devices. Any firm that manufactures, repackages, relabels or imports medical devices sold in the United States is regulated by the FDA's Center for Devices and Radiological Health (CDRH). Everything from x-ray and ultrasound machines to television sets and microwave ovens is covered by the CDRH.

Due to the complexity and seriousness of their purpose, we often assume that medical devices go through the most stringent of regulation processes. However, a recent report by Public Citizen, an advocacy group based in Washington, D.C., highlights what it refers to as "significant loopholes" in the approval process for medical devices. The study, release in the journal PLoS Medicine, found numerous areas of the process in need of improvement.

One of the main flaws cited in the study was the approval standard for medical devices. According to the FDA statute, a drug can be marketed only when it shows "substantial evidence" of effectiveness. However, a medical device can be marketed when is shows a "reasonable assurance" of safety and effectiveness.

The report also notes that pharmaceuticals must go through two or more well-controlled studies prior to approval; whereas some medical devices have a single study, or no clinical data at all, prior to premarket approval. The regulations also permit medical devices to rely "upon other valid scientific evidence ... even in the absence of well-controlled investigations," a standard that would not be permitted to approve a pharmaceutical.

Public Citizen argues that medical devices can cause harm to patients as great as, if not more than, over the counter and prescription drugs. Yet the study points to the differing statutory standards as evidence that devices reaching consumers are far less scrutinized than the drugs we take.

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