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Workshops

Event Date: 
Tuesday, January 30, 2018 to Wednesday, January 31, 2018

The Dental Trade Alliance hosts a regulatory meeting with the FDA  Center for Devices and Radiological Health staff during the first quarter of each calendar year to help DTA member companies better understand and prepare for regulatory changes that impact the dental device industry.

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.