The U.S. Food and Drug Administration as of recently proposed making another fast track to market for certain medical devices and a potential diminishment in the amount of safety information required for approval.
Commissioner Scott Gottlieb announced the proposal in a blog posted on the FDA’s site. On the off chance that implemented, it could save device organizations millions of dollars in product testing and shave a very long time off improvement times. The proposals follow through on President Donald Trump’s promise to cut regulations and sparked concern from public health advocates who fear the moves will harm patients.
Effectively many devices are recalled every year. Gottlieb’s proposal would offer an alternative route under the agency’s existing fast-track route, known as the 510(k) pathway, for certain companies which don’t meet the criteria for clearance.
To win 510(k) clearance a product should be a moderate risk and substantially proportionate to an existing device, called a predicate. High- risk products, for example, implantable heart devices must experience a more thorough process.
Gottlieb said that advancing technology means it can be hard for companies to identify a suitable predicate, “which can make an obstacle to certain kinds of innovation and prompt inefficiency in the review procedure.”
His new proposition would dispense rid of the requirement for a predicate and offer the option of utilizing a benchmark consisting of a set of performance standards or guidance documents. The plan would be voluntary.
Janet Trunzo, a representative for the industry organization AdvaMed, said the association “praises FDA’s commitment regarding elevating patient access to medical technologies through inventive regulatory pathways.”
Gottlieb said the FDA will also examine ways to speed the path to market for high- risk products by re-evaluating the measure of safety information required preceding approval.
The agency issues guidance shortly outlining “how certain issues could be ultimately resolved in the postmarket setting, rather than the pre-market setting, to enable patients to increase faster access to faster life- saving devices.”
Dr. Rita Redberg, a cardiologist at the University of California San Francisco and editorial manager of JAMA Internal Medicine, said shifting safety monitoring from the pre-approval to the postmarket setting would basically transform patients into guinea pigs.
“When we utilize devices on patients without clinical studies first, the patients effectively turn into the trial and the insurers become the founder of the device trial,” she said.