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Members Benefit from an Informative 2018 FDA Meeting & UDI Workshop

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

More than 35 DTA members attended the 2018 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. In addition, FDA Center for Devices and Radiological Health staff provided updated information about the new FDA divisions and how FDA plans to speed up the 510(k) application process.

On Jan. 30, members had the opportunity to meet with FDA review staff and ask questions about new 510(k) submissions, bringing devices to market sooner, radiography, sterilization, single use devices, and direct marking. The key takeaways were:

  • When submitting an application, always explain what the device does or what it is intended for. Don't assume the reviewer knows what the device does.
  • Read all the information pertaining to the submission process for 510(k)s. Many new Class I devices do not necessarily require a 510(k).
  • Labeling of devices must indicate if this device is intended (or not) for pediatric patients.
  • Many devices should now include in their submissions a section on cyber security protection for electrical devices.
  • FDA is undertaking a reorganization with restructuring.
  • FDA is geared toward better patient outcomes.

The next day, there was a UDI workshop where, among other relevant information, attendees learned about UDI rollout in the U.S. for Class I Devices, UDI harmonization in Europe and Asia, plus Brexit's impact on UDI in Great Britain. In addition, there was a demonstration of new UDI hardware and software. Big changes are coming to the European Union regulatory approval process for devices. Most U.S. companies selling devices in the EU will be required to get a new CE mark approval for their devices. This will cost time and money. It will require additional paperwork including any post-market surveillance for devices. Also, if there is no agreement reached in the next year, the United Kingdom will be considered a country with its own separate regulatory approval processes and fees.