WASHINGTON – The Food and Drug Administration unveiled a proposal Tuesday designed to speed up development and approval of medical devices that treat life-threatening diseases and debilitating conditions.
Under the Expedited Access Program, companies developing devices for critical and unmet medical needs would get earlier access to FDA staff to discuss their products. The agency says the earlier contact with regulators should result in “earlier access to safe and effective medical devices.”
The FDA already has a fast-track program for medical devices that are well-established, such as wheelchairs and hip implants. The agency’s new proposal is intended to accelerate approval for high-risk devices, generally those that support or sustain life.
Devices moving through the new review path would have to be medical breakthroughs or treatments for conditions that have no other treatments.