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Under the latest reauthorization of MDUFA, the agency only committed to providing complete performance reports on organizations with at least five 510(k) submissions. Read More
The Czech Republic is revamping its medical device reimbursement system and preparing for implementation of the new European device regulations. Read More
The agency “has not specifically evaluated implementation of the least burdensome requirements,” according to the Government Accountability Office. Read More
“We do not want to imply that all other decisions of the agency that do not fall within section 517A of the FD&C Act are not significant,” a new proposed rule states. Read More
CDRH released a three-year plan outlining three priorities to focus on: employee engagement, streamlining of processes, and building “collaborative communities.” Read More