FDA Unveils Plan for Expedited Device Approvals (ODTMag)
FDA Draft Guidance Document –> Expedited Access for Premarket Approval Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions
The U.S. Food and Drug Administration (FDA) has unveiled a proposal 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.
The FDA released a draft guidance on April 22 outlining its Expedited Access Program and will accept comments about the proposal through July.
“EAP is not a new pathway to market, but rather a collaborative approach to facilitate product development under the agency’s existing regulatory authorities,” the FDA wrote. “While other existing device programs have focused on reducing the time for the premarket review, EAP also seeks to reduce the time associated with product development.”
Eligible medical devices must be intended to treat or diagnose a life-threatening or irreversibly-debilitating disease or condition; or fill a treatment or diagnostic void; be a clinically meaningful breakthrough technology; offer a significant advantage over existing approved alternatives; or whose availability is in the patient’s best interest. Devices also must have a data development plan approved by the FDA.
The public has 90 days after publication of the draft guidance in the Federal Register to review the proposal and submit comments. The proposal is available here.