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The FDA is creating a largely automated surveillance system to monitor safety of high-risk medical devices, and has authorized a cellphone app for doctors to simplify reporting deaths and injuries to the agency.
Via Seth Bilazarian, MD, Lionel Reichardt / le Pharmageek
"There's an app for that." Physicians are often criticized for not doing a better job reporting adverse events and this is largely because the method for reporting to the FDA has been burdensome and difficult. An easy to use reporting strategy from a smartphone will increase my reporting dramatically. The speed of reporting and analysis by FDA for actionable items should be significantly shortened.