Medical Devices/Supplies

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3 Responses to “Medical Devices/Supplies”

  1. Helen Mannion Says:

    Is the FDA the equivalent to the MHRA (Medical and Health Regulatory Authority) in the UK?

    If not who is?

    If so, does the FDA give clinical approval on medical devices?

    and, does it govern the use of medical devices throughout the USA or do individual states have their own regulatory board?

    Regards

    Helen

    • Chris Conover Says:

      Yes, it is the rough equivalent. It approves medical devices for the entire U.S. There are no separate regulatory boards at the state level. However, some states have certificate of need programs that regulate the proliferation of medical devices. The issue is not whether Device X is clinically useful or safe, but instead how many and which institutions can purchase them for use. The concern is to avoid duplication of expensive medical equipment such as MRI machines, lithotripters and similar devices. But the same process is used in some states to regulate the number, types and distribution of hospital and/or nursing home beds, not just medical equipment.

  2. Helen Mannion Says:

    Thank you for your prompt response Chris.

    Regards

    Helen

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