2019 DTA FDA Program and Regulatory Workshop, April 17-18 (NEW DATES)
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, exclusive access Regulatory Affairs Meeting with FDA’s Center for Devices and Radiological Health and workshop. DTA has a long-standing working relationship with the 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 best device approval practices in China
- new rules on device audits and finding notified bodies for all international device sales
- the latest IAF information and international database for device certification and risk management
Hotel Reservations: Doubletree by Hilton Hotel room rate is $189 with a March 26 deadline.
Attendees can book by calling 1-800-HILTONS (or 1-800-445-8667) and request the group name: “Dental Trade Alliance FDA Regulatory Workshop” or Group Code: “DT1”
Attendees can also book online, direct at the hotel website:
- On the left side, enter arrival date 4/16/19 and departure date 4/18/19 and click on “Add special rate codes”
- In the box that appears for Group Code, enter your three letter code: DT1 (all capital letters)
- Click the green button for “CHECK ROOMS & RATES”
- Then simply click through the rest of the online reservations process until a confirmation of booking displays.
Speakers: Jay Crowley from USDM, Paul Brooks from RAPS, and guests from GS1 and ADVENA