DTA Members Have Successful 2017 Meeting With FDA Staff
In February 2017, 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.
In addition, FDA staff shared a number of mistakes that manufacturers make when submitting a new 510(k):
- Not clearly defining the intended use for a device.
- Making it difficult for the reviewer to find the statistical data referenced to support any claim.
- Not referencing the page and paragraph so the reviewer doesn't have to search high and low for it in the documentation.
According to FDA staff, approximately a quarter of the 510(k) submissions are sent back because of one of these simple mistakes. Approximately 4 out of 10 new medical devices submitted for 510k approval are dental devices.
During the workshop’s second day, DTA Regulatory Affairs Committee Co-Chair Grant Ramaley provided detailed information about changes to ISO 13489. He outlined exactly what companies need to know about the new changes to this important ISO so they can demonstrates their device(s) meets current regulatory requirements.