Suggested device approval revamp gets shrug from FDA
A recent IOM report calls for a total rethink of the agency's 510(k) process, by which the similarity of “moderate risk” premarket devices like artificial hips to approved devices is assessed, but not their safety or efficacy.
The device industry, unsurprisingly, disagreed strongly, with trade group AdvaMed, in what The New York Times called “an unusual preemptive strike,” saying the report “does not deserve serious consideration from the Congress or the Administration. It proposes abandoning efforts to address the serious problems with the administration of the current program by replacing it at some unknown date with an untried, unproven and unspecified new legal structure.”
FDA's response was muted. The agency, which commissioned the report in 2009, opened a 30-day public comment period on the matter and issued a statement that said, in part: “FDA believes that the 510(k) process should not be eliminated but we are open to additional proposals and approaches for continued improvement of our device review programs.” Some of the changes advocated by the IOM, the agency noted, would require Congressional action.
Proponents of a root-and-branch approach argue that consumers have a right to expect the same rigorous review of safety and efficacy applied to drugs of the devices they use.
“As a matter of law and logic and science, the report makes a lot of sense,” said food and drug law expert Arnie Friede. “It's not a safety or effectiveness review and if we want that in our regulatory regime, the 510(k) process ain't it. The IOM basically said this thing is so broken it can't be fixed, and it's a largely accurate assessment of the shortcomings of the process.”