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DTA hosts various in-person workshops throughout the year, usually in conjunction with major dental meetings.  These are excellent opportunities to learn about industry trends, market data, technology, regulatory issues and more.

Original Recording Date: 
Wednesday, February 1, 2017

DTA members met with FDA Branch of Device and Radiography 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):

  1. Not clearly defining the intended use for a device.
  2. Making it difficult for the reviewer to find the statistical data referenced to support any claim.
  3. 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.

Original Recording Date: 
Thursday, February 25, 2016

Recently, DTA hosted two back-to-back meetings with the FDA and more than 60 member companies. The first meeting was with the staff from the FDA Branch of Devices and Radiological Health and was followed the next day with a workshop dedicated to Unique Device Identification (UDI) implementation.

The exchanges with FDA staff were meaningful, lively, and very interactive. DTA attendees and FDA staff all agreed that the meeting and the information presented was of great value in helping all parties deal with the various regulatory issues affecting patient and practitioner safety.  In response to overwhelmingly positive feedback, FDA staff members indicated that they are willing to consider a follow–up event. In addition, there were many other positive takeaways from the two-day event.

Original Recording Date: 
Tuesday, July 7, 2015

Manufacturers must begin preparing to create and upload their device UDIs–specifically the device information (DI) to the GUDID website for the Sept. 24, 2016 deadline for Class II devices. During the workshop, presenters spent a lot of time discussing the pros and cons (and what is involved) when each company uploads the UDI data on the GUDID website. There was concern that the website and the FDA help desk may be overwhelmed when manufacturers start uploading information for all the Class II devices sold in the U.S. The best estimate is that 10,000 to 20,000 companies will be uploading their Class II devices starting next year.

Original Recording Date: 
Tuesday, March 3, 2015

On March 3, DTA held a meeting with the FDA Dental Branch and other FDA staff in Silver Springs, Md., to discuss accelerating 510(k) approvals, reprocessing dental devices, implementing UDI and the role of dental standards.  More than 30 industry leaders, including representatives from ADA and the Veterans Administration, participated. Attendees praised the meeting for being an unprecedented event in other medical device segments as well as a unique opportunity to hear comments from the FDA and the opportunity to have an open and spirited exchange. 

The following day, DTA members met to discuss the implications of what was learned, how we might best work with FDA in the interest of all stakeholders, among other topics.  Leadership from the ADA Standards Committees for Dental Products and for Dental Informatics participated in both days and representatives of DTA are attending their upcoming committee meetings.

Watch your e-mail for the next DTA regulatory and standards digital newsletter, which will include some specifics about the aforementioned meetings, including the FDA presentation at the ADA Standards Committees for Dental Products.

DTA works hard on your behalf to help ensure that regulations and standards are not unduly burdensome on members. With continued DTA member engagement in the regulatory, standards and legislative processes, DTA can be more effective in addressing members’ concerns. We look forward to even greater participation in the coming years.

Keep in touch to learn more about upcoming meetings to include other regulatory agencies and more FDA Branches.