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FDA Calling For More PMAs Than 510(k)s In Final Set Of Preamendment Devices

“The Gray Sheet” reviewed CDRH’s proposed orders and final classification decisions on preamendment devices targeted by the 515 initiative. As of Aug. 5, FDA has proposed or finalized 14 PMAs, and proposed or finalized 10 products to be downclassified to class II with special controls.

FDA has leaned toward requiring more PMAs than 510(k)s for preamendment medical devices since it launched its focused risk classification effort in 2009. Although there have been some complaints, stakeholders generally say the agency has taken an even-handed approach to revising regulatory requirements under its “515 program initiative.”

“I think they’re using an appropriate risk-based, scientific approach, where they’re analyzing each device very carefully and making the appropriate...

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