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2019 DTA and FDA Program and Regulatory Workshop

Event Date: 
Tuesday, February 5, 2019 to Wednesday, February 6, 2019
Time: 
7:30 am:  Continental breakfast each morning.
Day One:  8:30 am – 4:00 pm program with working lunch.
Day Two:  8:30 am – 3:30 pm workshop with working lunch
Location: 

Doubletree by Hilton Hotel, 8727 Colesville Road, Silver Spring, Maryland (metro accessible)

Registration Fee: 
Two Day:  $299 per person One Day:  $199 per person (specify which day)

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

Hotel Reservations:  Doubletree by Hilton Hotel room rate is $149 with January 11 deadline.   Reservation Link

Speakers:  Jay Crowley from USDM, Paul Brooks from RAPS, and guests from GS1 and ADVENA

Click Here to Register