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Devicemakers planning a PMA or product development protocol should take advantage of presubmission determination meetings with the FDA to pin down exactly what data the agency expects to support safety and efficacy of a new product. Read More
CDRH plans to reduce the number of IDEs requiring more than two cycles to make a determination by 25 percent by Sept. 30, and by 50 percent by June 30, 2015. The aim is to get the median time for full IDE approvals down to 30 days by June 30, 2015. Read More
The FDA’s Center for Devices and Radiological Health is working on ways to permit sponsors to use more adult clinical trial data in proving the safety and effectiveness of pediatric medical devices. Read More
Devicemakers should note whether changes to PMA devices were due to enhancement, product complaints or adverse events when preparing annual reports for the FDA, new guidance released Friday says. Read More