FDA Product Review Committee

M

MegSinha

FDA Product Review Committee
I was wondering if someone could help me out with my query,
Taking an example, if a product "A" by intended use falls under cardiovascular review committee but according to product regulation explanation has a product code XYZ that falls under a different review committee, lets say general hospital, is it acceptable for that product to be classified as XYZ or should the product be classified according to the intended use and the appropriate review committee?

Please Advise. Thanks
 
M

MIREGMGR

If you're developing a device that will be Class II at most:

Don't start by deciding who will review or what the classification might be. Start by identifying the best predicate. That choice then determines the classification and the review panel.

If you have several good predicate choices, you likely will want to consider their classification implications, especially if at least one choice puts you in Class I. If all the choices are Class II, you may want to consider the review panel each would yield in deciding between them. But start by identifying the predicate.
 
Top Bottom