Slow approval of mobile medical applications? FDA: don't make trouble, for your safety!

Source: on February 26, 2014, in response to industry complaints about the slow approval of U.S Food and Drug Administration (FDA) for mobile applications, bakul Patel, a senior policy consultant of FDA, said at the preparatory meeting of himss14 conference held from February 23 to 27 that 80% of the approval work was in the specified 90% Completed within days In September last year, the FDA released guidelines for the development of mobile medical applications, the main author of which is Patel Patel told the himss14 conference that the regulatory review is mainly based on application risks, especially those that may bring great risks to patients Patel also said that if the "narrow definition method" is adopted, most applications do not need to be actively reviewed by the FDA, because they are not among the medical devices defined in the food, drug and Cosmetics Act For those medical devices that meet the definition of the food, drug and Cosmetic Act, if the risk to users is very small, FDA will exercise discretion, which means that FDA will not make mandatory requirements according to the provisions of the food, drug and Cosmetic Act So far, FDA has evaluated more than 100 mobile medical applications, including remote blood pressure and heart rate monitoring, as well as ultrasonic, ECG and glucose monitoring based on smart phones The FDA told Congress last year that the average time to review mobile medical applications is 67 days Still, Congress has begun to press the FDA At present, two proposals have been submitted to the house of Representatives and the Senate of the United States, hoping to amend the food, drug and Cosmetics Act and limit the regulatory power of FDA "We also want to innovate," Patel said But at the same time, we need to ensure the safety of our patients These are two equally important goals "