Brazil’s medical device industry faced a number of challenges in recent years: a complex regulatory process created long delays for approvals and a tumultuous economic...
FDA Pilot Program for Medical Device Review Tool Development in the Works
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 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.
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