FDA regulations on medical devices

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Job Description

Requesting for a summary on the regulations for medical devices that requires pricking on the fingers. There are devices in the US to diagnose diabetic patients by using a prick test, to draw blood from the finger to test the blood. Prick would be very small and the size and amount of blood drawn is similar to the one used for insulin check.

I am thinking of making a similar device but for a different application, and want to know what are the barriers to entry in terms of the regulation in the US (and around the world): any necessary specifications; bandage requirements, frequency limits of use; requirement of needle size; amount of blood that can be drawn, biohazard disposal, etc.

What would be the biggest barrier to entry for a startup to enter this space?