The new guidelines replace the 1997 guidelines for 510(k) submission. Included is a new section on how to evaluate changes to the medical device. Many changes may mean you can’t claim “substantial equivalent” you may have to make a new submission of 510(k) paperwork, this article says.
FDA Release Asking for Input into medical device approval- Aug. 15 2011- found here.
Always mindful of facing a product liability injury or death lawsuit the author says, “Failure to follow the new guidance and to understand its implications could result in additional product liability suits against manufacturers.” Best to follow the letter of the guidelines she suggests.
*Interesting to note- the author raises the question- does this move toward more consumer safety mean that manufacturers who get their devices on the market without premarket approval and clinical trials, may be able to enjoy the preemption protections of approved devices?
The Supreme Court granted device makers a liability pass in the Riegel v. Medtronic, Inc. decision arguing that an FDA pre-market approval (PMA), requiring hours looking at clinical studies and requiring some proof of safety means consumers can’t second guess the FDA.
End result- forget bring a medical device manufacturer to court if the defective device hurts, maims or kills someone. Device makers breathed a sigh of relief when the Medtronic decision was rendered.
Now comes the pesky devices that do NOT undergo PMA. Instead, they get into the marketplace after a 510(k) paperwork review claiming they are substantially equivalent to another device. They DO NOT undergo pre-market approval, therefore are not sanctioned by the FDA, so technically a 510(k) is not immune from a personal injury lawsuit.
This author points out that with the proposed new guidelines, 510(k) devices might be able to claim they too are exempt from lawsuits because they have undergone a heightened safety approval proves.
“The changes in the new guidance appear to have a much more safety-oriented theme. Once the new guidance is finalized, one could argue that by eliminating the substantial equivalence process and replacing it with a more safety oriented process, 510(k) devices should now enjoy the same preemption protection that PMAs do.”
No matter how you slice it a 510k is not premarket approval as it now stands. You can’t have it both ways. #