FDA Plans Number Of Deregulatory Actions In Medical Device Space

FDA is planning to move on a range of deregulatory actions in the medical device space, including implementing the timeframes and procedures for how the agency handles internal review of device-related decisions; no longer publishing lists of certain device approvals and denials; and harmonizing domestic and international quality requirements for devices. The FDA announced its plans in the agency’s fall 2018 regulatory agenda, released Tuesday (Oct. 16). The agenda lists 10 device-related rules, six of which are deregulatory and seven...