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2019 DTA-FDA Meeting

 Registration is closed for this event
The Dental Trade Alliance hosts a regulatory meeting with the FDA Branch of Device and Radiography 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.

If you sell devices or plan to sell devices on the international market, don’t miss this two-day program! 

 

Join the DTA for a member only, special access Regulatory Affairs Meeting with FDA’s Center for Devices and Radiological Health and workshop. DTA has a long-standing working relationship with FDA and provides great pathways for members to learn about new changes in the dental device world and to work with the FDA on current and future initiatives in the industry.  Space is limited so be sure to register early.

 

Day One:  A full day program with presentations by senior FDA Staff and reviewers from FDA’s Center for Devices and Radiological Health covering such topics as:

  • new 510 (k) submissions
  • changes to how the FDA handles new technology submissions
  • updates on UDI and direct device marking
  • acceptance of New Standards for devices
  • MDSAP and new fees for industry
  • Q & A and a working lunch with FDA staff

 

Day Two:  A full day workshop that will feature important updates on:

  • new European Device Regulations and European UDI
  • the latest Brexit information for selling devices inside the UK
  • tariffs and conducting business in China
  • new rules on device audits and finding notified bodies for all international device sales
  • the latest IAF information and international data base for device certification and risk management

     

When
April 17th, 2019 8:30 AM   through   April 18th, 2019 3:30 PM
Location
DoubleTree by Hilton Hotel Silver Spring
8727 Colesville Rd
Silver Spring, 20910
United States
Contact
Phone: 703-379-7755 (DTA Office)
Registration Fee
FDA Regulatory Meeting Only (April 17th) $ 199.00
UDI Workshop Only (April 18th) $ 199.00
FDA Regulatory Meeting & UDI Workshop (April 17-18) $ 299.00