The FDA device II approval process is slowed by bu

The FDA device II approval process is slowed by bureaucracy and science! Been waiting to receive approval for UEEC with their hemostyp gauze for a year now. The PMA rules could apply to Innova's but I blame it on big pharm politics! Abbot received theirs in a timely manner then end up having it pulled. For one, drugs and devices often make it to market simply because the manufacturers can demonstrate they are similar to products that were approved in the past — even if those products have since been recalled or have known problems. In fact, manufacturers recall about 4,500 drugs and medical devices annually. It is a new device to the market!
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