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The FDA will be looking for new authority to regulate diagnostics, Commissioner Scott Gottlieb said in a session on precision medicines at the World Economic Forum in Davos, Switzerland. Read More
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