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February 25, 2010

FDA Claims it Lacks Some Power Over Medical Device Sector

The US Food and Drug Administration (FDA) has admitted it lacks certain powers over the medical device industry. FDA officials said the body lacked the power to recall devices already on the market and it could not adequately oversee how manufacturers label their products. The

By cms admin

The US Food and Drug Administration (FDA) has admitted it lacks certain powers over the medical device industry.

FDA officials said the body lacked the power to recall devices already on the market and it could not adequately oversee how manufacturers label their products.

The announcement was made at a meeting of government officials and industry representatives where alternative approval processes, including moderate-risk devices, such as orthopaedic knee and hip replacements, were discussed.

Currently, the approvals process, called 510k, is for when companies want to sell a new device based on an existing product.

The approvals process for high-risk medical devices, such as heart implants, is not under intense review.

Industry officials said they fear any changes to the current system would see investment disappear and harm patient care.

They said the FDA was in danger of acting irrationally and erecting hurdles that are too high.

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