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FDA Issues Draft Guidance for Safer Technologies Voluntary Pathway

NEW YORK – The US Food and Drug Administration this week issued a draft guidance for a new voluntary pathway that it anticipates will "significantly improve" the safety of available treatments or diagnostic devices for diseases or conditions that are less serious than those eligible for the agency’s Breakthrough Devices Program.

The FDA said that its Safer Technologies Program for Medical Devices that may be associated with serious or life-threatening risks was modeled after the Breakthrough Devices Program, a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating conditions.

The Safer Technologies Program for Medical Devices will include interactive and timely communications with the FDA, review team support, senior management engagement, and prioritized review, the FDA said. Devices and device-led combination products are eligible for the program if they are subject to review under a premarket approval application (PMA), De Novo classification request, or premarket notification (510(k), and meet program eligibility factors as described in its guidance, the FDA said.

The agency added that the interactive program may reduce the total time to develop a device and achieve marketing authorization, while still meeting its standards for safety and effectiveness.

The FDA said stakeholders should submit comments and suggestions regarding the draft guidance within 60 days of its publication in the Federal Register.