The FDAnews report EU MDR Compliance can help. Our editors have combed through the regulations, picking out the most minute compliance points and building them into a checklist of 200+ requirements you can use to confirm that you are satisfying all the EU mandates for device manufacturing.
Devicemakers have until Nov. 6 to submit comments on the FDA’s transparency task force ahead of a planned second public meeting this fall. The agency reopened the comment period as planned to gather more information on ways to make data on its activities and decisionmaking more accessible while protecting confidential information, the agency says in a recent Federal Registernotice. The task force announced in June is led by FDA Principal Deputy Commissioner Joshua Sharfstein and includes the agency’s center directors, associate commissioner for regulatory affairs, chief scientist and chief counsel. Devices and Diagnostics Letter