The U.S. Food and Drug Administration on Monday proposed creating a new fast track to market for certain medical devices and a potential reduction in the amount of safety data required for approval.
Commissioner Scott Gottlieb announced the proposal in a blog posted on the FDA’s website. If implemented, it could save device companies millions of dollars in product testing and shave years off development times.
The proposals make good on President Donald Trump’s promise to cut regulations and sparked concern from public health advocates who fear the moves will harm patients. Already dozens of devices are recalled each year.
Gottlieb’s proposal would offer an alternative route to market for certain companies which do not meet the criteria for clearance under the agency’s existing fast-track route, known as the 510(k) pathway.
To win 510(k) clearance a product must be a moderate risk and substantially equivalent to an existing device, called a predicate. High-risk products such as implantable heart devices must go through a more rigorous process.
Gottlieb said that advancing technology means it can be hard for companies to identify a suitable predicate, “which can create an obstacle to certain kinds of innovation and lead to inefficiency in the review process.”
His new proposal would dispense with the need for a predicate and offer the option of using a benchmark consisting of a set of performance standards or guidance documents. The plan would be voluntary.
Janet Trunzo, a spokeswoman for the industry organization AdvaMed, said the organization “commends FDA’s commitment to promoting patient access to medical technologies through innovative regulatory pathways.”
Gottlieb said the FDA will also examine ways to speed the path to market for high-risk products by re-evaluating the amount of safety data needed prior to approval. The agency will issue guidance shortly outlining “how certain issues could be ultimately resolved in the post-market setting, rather than the pre-market setting, to allow patients to gain faster access to potentially life-saving devices.”
Dr. Rita Redberg, a cardiologist at the University of California San Francisco and editor of JAMA Internal Medicine, said shifting safety monitoring from the pre-approval to the post-market setting would essentially turn patients into guinea pigs.
“When we use devices on patients without clinical studies first, the patients effectively become the trial and the insurers become the funder of the device trial,” she said.
Others echoed Redberg’s concern.
“I see a potentially huge problem in moving more risk to the post-approval setting,” said Areta Kupchyk, a partner at Foley Hoag and former associate chief counsel at the FDA. “It’s very difficult once a product has been approved to pull it back.”
(This version of the story corrects the 10th paragraph to add the dropped word ‘essentially’)
(Reporting by Toni Clarke in Washington; Editing by Cynthia Osterman and James Dalgleish)