What is the name of the specific FDA regulation for medical devices?

Where can I get some info. I went to the FDA but they have so much that i cant find it. I know its some kind of article....some kind of number. 109? Or something like that.
please help me. thanks.

Medical Devices are classified into 3 categories. Different conditions apply to each class. Further, many devices (example Heart Valve Prosthesis) have individual AAMI standards which will be applied by USFDA.

There is something known as 510K situation, which refers to devices that are substantially similar to devices already on the market and certified by FDA. It is much faster to get a certification in these cases.

This site will give you a lot of (Confusing?) info.
http://www.fda.gov/cdrh/

The entire FDA is set up through a body of law. Some of that law then also falls back on the larger body of law of the US. Those laws (which the FDA does not pass because no one in the Executive Branch writes or passes laws), are then enacted through a rules process (which the FDA has really abused in some instances).

It's from this large amalgam that regulations are enacted.

It depends on what kind of medical devices you're talking about because newer technologies and modalities often result in a new rules formation.

You may be ahead of yourself in your search. By this I mean that you may want to consider a Google search for the device using the name of the device and then "search within the results" using "medical necessity". This will likely bring up results for major carriers like Aetna, BlueCross BlueSheild, Cigna, etc., for which you may review their position and find additional resources for FDA approval. Hope this helps!

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