2018 DTA-FDA Meeting
DTA members are encouraged to sign up for an eye-opening UDI and regulatory meeting with the FDA Branch of Devices and Radiography on Jan. 30 at the Doubletree Hotel in downtown Silver Spring, Maryland. In addition, a UDI workshop will be held on Jan. 31 featuring Jay Crowley.
USDM Life Sciences Vice President Jay Crowley is the former senior advisor at FDA for patient safety for devices and radiography. He spearheaded the creation and rollout of the UDI system for devices in the U.S. distribution channel.
At the Jan. 30 meeting, DTA members will have an opportunity to meet with FDA review staff and ask questions about important topics. Discussions will focus on hot button topics including new 510(k) submissions, bringing devices to market sooner, radiography, sterilization, single use devices, direct marking, UDI rollout in the U.S. for Class I Devices, UDI harmonization in Europe and Asia, Brexit's impact on UDI in Great Britain. In addition, there will be demonstrations of new UDI hardware and software.
On Jan 31, there will be a workshop on all things UDI including international harmonization. Attendees will have an opportunity to ask direct questions regarding specific questions about how to properly submit new 510(k)s including software, discuss design issues with FDA reviewers, better understand how to mitigate risk, hear about new suggested parameters for pediatric patient exposure to radiography, discuss single use device versus reprocessing of multiple use devices, understand direct marketing for small devices and discover devices that make up multiple device kits. In addition, attendees will get to see demonstrations of new UDI readers and software/hardware for uploading and printing UDI labels.
The cost to attend both days is $299 per person. The cost to attend only one day is $189 per person. The program includes breakfast, working lunch, snacks, breaks and all presentations.
Attendees will need to contact the Doubletree Hotel (301-589-5200) separately to reserve their sleeping rooms in the DTA room block. Hotel sleeping rooms in the DTA room block must be made on or before Jan. 10.
Click here to register or use the Event Registration drop down menu.