Does the FDA Overregulate Devices? Experts Weigh In

Monday, March 23, 2015

Source: Fierce Medical Devices

Opinions are all over the map when it comes to whether the FDA regulates medical devices too strictly or too loosely. Those favoring more regulation point to infamous examples like metal on metal hips and faulty defibrillator leads. Power morcellators and duodenoscopes are the latest additions to that list. Industry and others who favor faster access note that in Europe, many advanced devices are made available years before they are commercialized in the U.S.

The conflicting opinions and evidence reflect the complexity of the task facing the FDA and its device arm, CDRH. The Wall Street Journal convened three experts for a roundtable discussion about device regulation.

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