FDA Slow to Approve Medical Devices

An industry survey shows that medical devices are approved in Europe about two full years earlier than when the device is approved by the U.S. Food and Drug Administration in the United States. For standard medical device approvals, approvals take 54 months in the U.S. compared to 11 months in Europe. There is no evidence of compromised safety in Europe due to premature approvals.


Comments (4)

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  1. Brian Williams. says:

    “Slow” is an accurate adjective to describe almost any function of goverment. But 54 months to approve a medical device is ridiculous. Maybe the FDA should take some advice from the DMV on how to speed things up.

  2. Devon Herrick says:

    Most people do not realize that FDA-regulated medical devices include thousands of household items. Your toothbrush, feminine hygiene products, over-the-counter birth control, etc. Most of these do not need approved but it’s a huge list.

  3. Ken says:

    Can we conclude that the FDA is the world’s worst regulator?

  4. Bruce says:

    The FDA kills. I thought everybody already knew that.