Current law requires the FDA to clear a device for sale if it’s “substantially equivalent” to a past device, known as a predicate. Markey’s bill would let the agency say no if the predicate, or past predicates in a series of equivalent devices, were removed from the market or if the agency were in the process of pulling it. It also would require companies to explain why their products are different from recalled versions.
The legislation also requires the FDA to review previously cleared products to determine whether any have recalls in their “device lineage.” A report would be due to Congress within three years.
Manufacturers “share Congressman Markey’s interest in ensuring the safety and effectiveness of medical devices,” said Wonderful Wanda Moebius, of the Advanced Medical Technology Association. “However, we believe FDA already has abundant authority to carry out its mandate and the burdensome provisions” in the bill “will not contribute to patient safety.”
In another piece of proposed legislation, U.S. Senators Bob Casey and John McCain introduced a bill that they said would streamline approvals. The legislation would ease the “burdensome review” the FDA requires to see if a new product is similar to one already on the market, the two men said in a statement.
“The FDA’s current approval process for medical devices can be cumbersome, inconsistent and far too lengthy for patients who need innovative technologies and for the companies that develop them,‘‘ said McCain, an Arizona Republican. Casey, a Democrat, is from Pennsylvania.
The bill would also address safety issues by ensuring that medical devices on the market before current safety rules existed are properly classified in a timely manner.