By Stewart Eisenhart, Emergo Group
A new pilot program planned by the US Food and Drug Administration is being planned to develop tools for more effective and efficient reviews of medical device premarket applications.
According to new guidance, the agency will begin seeking participants for its Medical Device Development Tools (MDDT) Pilot Program in September 2014. Qualified MDDT program participants would develop tools for use by both regulators and manufacturers to evaluate performance, safety and effectiveness of devices before and during their US premarket registrations.
Appropriate tools for participation in the MDDT program include clinical outcome assessments; nonclinical in vitro, animal and computer assessment models; tools to determine how innovative devices may impact public health; and tools that would boost efficiencies in device development and commercialization time frames.
Developers interested in participating in the MDDT pilot program should submit proposals to the FDA. The agency will accept requests for participation and run the pilot program until finalized MDDT guidance is published; any decision to end or extend the program will be published in the US Federal Register.
Several device categories are targeted for 510(k) exemption by the guidance, including anesthesiology, cardiovascular, dental and ophthalmic devices. A full list of qualifying devices is available in the guidance document.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.