Many companies have been involved in medical device litigation for defective product designs and failure to adequately warn claims. The litigation often precedes a voluntary recall. Many critics have argued that an overly-lenient FDA approval process is partly to blame for the increase in medical device defects and injuries reported.
Here is a general summary of the two types of processes a manufacturer can utilize to gain FDA approval to access the U.S market to sell medical devices:
Pre-market Approval Process (PMA): The pre-market approval process requires a medical device company to submit safety and efficacy data on the proposed device. PMA is a longer and more expensive process, and typically these products include innovative, cutting-edge technology.
A 510K Process: The 510K approval process, however, allows medical devices to obtain FDA approval without submitting safety and efficacy testing data. A company may introduce a new medical device if the device is a “substantial equivalent” to another device that previously went through the more rigorous pre-market approval process discussed above.
Many device models are put to market under the more lenient 510K pre-approval process and are not properly tested. This puts American consumers and recipients at risk of serious injury.