Who "lost" medical technology?
At an FDA-sponsored public meeting in Irvine, California, CDRH Director Jeff Shuren shared that new regulations for approving medical devices may include a new category for medium-risk products. Products in this category would require more studies on safety to win agency clearance. According to Shuren, changes will be phased in and that changing the rules may not result in more studies being required of device makers initially. “We are still addressing that on a case-by-case basis where it’s appropriate and necessary, he said.
Is more data always better? Sometimes. But how does this weigh against the growing “device gap” between the US and the EU? It seems that what’s old is new again – and not necessarily for the better.
When the agency determines it needs more data for an approval or that a device application should fall under a new designation, consideration must also be given to what’s going on “over there.” We cannot and must not create a regulatory environment for medical technology (or, for that matter, pharmaceuticals) that exists in isolation from the rest of the world. Harmonization mustn’t mean “do it our way,’ but rather, “let’s talk.”
