FDA drones? Maybe not -- K Trade Fair

FDA drones? Maybe not


Can you say, doh? Just a few hours after confirming to the Raps Regulatory Affairs Professionals Society (RAPS; Rockville, MD) that it was considering the use of drones to assist in on-site facility inspections, FDA announced that it had cancelled its "preliminary feasibility testing." Apparently, someone had second thoughts.

An FDA spokeswoman told Regulatory Focus, which is published by RAPS, that, while there is no formal program in place, the agency is "conducting feasibility testing on possible applications for drone technology in fulfillment of the agency's mission." FDA is supposed to conduct inspections of registered medical facilities producing Class II or Class III devices every two years and is also mandated with inspecting other manufacturing sites and agricultural concerns. Limited resources make this difficult, so it's easy to see why eyes in the sky might seem like a good idea.

Regulatory Focus reports that an e-mail was sent to FDA staff on Dec. 18 saying that it planned to perform a test of drone technology at FDA's campus this week. Today, the agency released a new statement saying that FDA has cancelled all future testing of drone technology.

"FDA would like to underscore that the agency does not have an aerial device (or "drone") program in place," spokeswoman Andrea Fischer wrote in the statement addressed to Regulatory Focus. "The e-mail that was sent to DC-area FDA employees this week related to testing that FDA's Office of Informatics and Technology Innovation (OITI) was planning to do on emerging technologies for research and development purposes."

Well, that certainly clarifies things. Doesn't it?


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