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Workshops

(From R-L) Michael Adjodha (FDA), Dr. Susan Runner (FDA), and Dr. Mohamed Harunani (ADA)

More than 35 DTA members attended the recent FDA Meeting and UDI Workshop hosted by the Dental Trade Alliance. During the meeting, members had the opportunity to speak directly with FDA reviewers who approve their new 510(k) device applications.

DTA members met with FDA Center for Devices and Radiological Health staff to discuss 510(k) submissions, the 21st Century Cures Act, as well as device reprocessing and sterilization. Unique Device Identification implementation updates for Class II Devices was also covered, along with, dental and device standards, software as a device, and cyber security concerns.

The number one takeaway from the meeting was a new interpretation from FDA staff that any medical device that does not come with proper reprocessing instructions will now be considered a single-use device, even if the manufacturer intended the device for multiple uses.