I read today that there is a group proposing some significant changes to FDA’s 510(k) process. In case you are unaware, a 510(k) is a submission to the FDA for most class II medical devices. The purpose of the submission is demonstrate substantial equivalence to a product that already has 510(k) clearance. Very few class II devices require actual clinical use before receiving clearance. And it seems that this fact has this particular group up in arms.
I personally think the current regulatory processes and submissions are adequate. What do you think?