FDA Gets Flak For Medical Device Regulations

medical device

The Food and Drug Administration (FDA) is being criticized for its strict regulation of new medical devices. Companies manufacturing medical devices are shutting down operations in the U.S. and investing elsewhere in the world. U.S. citizens are being forced to travel to Europe to get device implants.

Experts in the medical device business say the FDA’s over-zealousness is harming the industry. They say this tough approach will cripple innovation and slow down investments in a weak economy. But, there have been recalls of certain poor quality medical devices such as hip replacements and implanted defibrillators.

On its part, the FDA has promised to speed up reviews of path-breaking devices. The agency says its review process will be made predictable and consistent to stimulate investment and jobs in the U.S. It also reiterated that standards would not be relaxed, saying the European system could be lax. The FDA pointed out examples of an elbow fracture implant, a lung sealant and a breast implant which got approval in Europe, but had to be recalled because of safety issues.

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