FDA Plans New Rules for Medical Device Makers


An important lunchtime looms for one of America's smartest industries—medical devices.

At 1pm, ET, Wednesday, the Food and Drug Administration (FDA) will announce new rules for how it intends to license orthopedic players—specifically hip, knee and and spine products.

In broad terms at the moment, though in laboratory testing, the producers demonstrate the equivalence of their new products to what exists in the market.

Analysts say they are watching for potentially two thresholds. One is a requirement to submit "all information relevant to their product." More than coming up with, say, one page of dense information, analysts say that could mean may be 100 pages, aimed at getting FDA officials thinking along the right lines for further discussions.

The second possible new regulatory threshold would be to create a new class of product within the space for which the FDA demands requires "full clinical trials" of any new product.

Human testing would clearly be far more expensive and delay the ability of innovators to bring products to market. Analysts also that their ratings on big orthopedic stocks are not necessarily at stake here. But that smaller, start-up innovators could be very adversely affected.