Regulatory News

FDA Studying How it Can Use Drones to Conduct Inspections (Updated)

The US Food and Drug Administration (FDA) is considering the use of aerial drones to help assist its on-site inspections of facilities, the agency confirmed to Regulatory Focus this week.

UPDATE: FDA has cancelled its preliminary feasibility testing.

While there is currently "no formal drone program in development," the agency is currently "conducting preliminary feasibility testing on possible applications for drone technology in fulfillment of the agency's mission," Andrea Fischer, an FDA spokeswoman, told Focus.

Using drones during FDA inspections of manufacturing facilities could have far-ranging implications. Inspections could, for example, much more easily survey an entire manufacturing site, which can sometimes span several acres and include difficult-to-access sections, such as rooftops. In agricultural settings, in particular, the use of drones might allow FDA to survey an entire site much more easily.

For now, FDA's feasibility testing appears to be at a very early stage. In an email sent to FDA staff on 18 December 2014, the agency said the program is being headed up by its Office of Informatics and Technology Innovation (OITI) under the auspices of Chief Health Informatics Officer Taha Kass-Hout.

Kass-Hout has been at the heart of several agency efforts to leverage technology for the benefit of FDA and the public, including FDA's openFDA website, which allows the public to track drug and medical device recall data much more easily.

FDA's email to staff said it planned to "perform a test of drone technology" at FDA's campus this week, but an FDA source indicated that test had later been canceled.

The email said FDA intended to use the drone technology "in the areas of manufacturing site inspections, farm inspections, or land area inspection surveillance."