- FDA may soon offer a quicker path to market for companies looking to sell certain medical devices and device-led combination products expected to "significantly improve" safety compared to existing treatments for non-life-threatening diseases.
- The agency Wednesday morning published draft guidance laying out its Safer Technologies Program (STeP), mirroring some aspects of Breakthrough Devices Program, such as boosted communication, senior management engagement and prioritized review, to certain products that do not qualify for the breakthrough designation.
- First previewed in the agency's Medical Device Safety Action Plan, the effort is intended to incentivize innovation toward safer medical devices. FDA said in its new draft guidance it will need 60 days after issuing the final guidance to operationalize the program before accepting applications from sponsors.
For acceptance into the program, FDA says devices should reduce the occurrence of known serious adverse events, device failures, use-related hazard or error, or an improvement in the safety over another device.
"FDA believes that efforts to improve safety are directly related to improving overall clinical benefits and may also help patients experience fewer serious adverse events," the draft guidance states.
To participate in the program, manufacturers will first request inclusion in the program through a Q-submission. In the second phase, FDA will work with sponsors to expedite development of the device followed by prioritized review of pre-submissions and marketing submissions.
FDA notes external experts or advisory committees may be tapped for help reaching regulatory decisions on novel scientific aspects of products in the program.
Mike Carome, director of Public Citizen's Health Research Group, told MedTech Dive the action by FDA is the latest effort to accommodate device manufacturers in what he argues is an already lax medical device regulatory regime.
Still, he doesn't believe the program would significantly change agency backend processes.
"On initial review, I don't think it substantially weakens the standard for clearing or approving devices," Carome said.
The agency also notes acceptance into STeP does not change the statutory standard of a reasonable assurance of safety and effectiveness for premarket approval or De Novo devices.
"We believe the Safer Technologies Program for Medical Devices will help ensure that we’re giving patients timely access to safe, effective and high-quality medical devices by expediting their development, assessment and review, and by facilitating the generation of the robust evidence required to support product marketing authorizations," FDA device chief Jeff Shuren said in a statement.
FDA is holding a webinar on the STeP draft guidance on Nov. 6. Comments on the draft guidance are due 60 days after it is published in the Federal Register.