Implementing UDI will have many challenges, especially for the small manufacturer. Now is the time to start planning your approach and identify the resources you need. You can avoid the last minute scramble.
Implementing UDI: Meeting the Challenges
An Ombu Enterprises Seminar
Ombu is offering two local seminars to help you prepare.
Springfield, MA April 18, 2014
Albany, NY May 2, 2014
Implementing UDI : Meeting the Challenges is a seminar you cannot afford to miss because it addresses all aspects of the UDI rule. You will receive tools to help you understand the regulations, update your procedures, and make the critical decision you need for implementation.
Many of the challenges come from the complexity of the regulation, the many decisions you must make, and the resources you must provide.
Do you know the compliance date for your device? The device class is one factor, but other factors enter as well. You must have everything in place by your compliance date.
The rule will change the label on your device and your packages to include the UDI = DI + PI and a new date format. The DI (Device Identifier) is mandatory, but the PI (Production Identifiers) are optional. How will you decide which ones to use?
Have you established the packaging hierarchy for your devices so you can put the correct UDI on each packaging level?
On the compliance date, your labels and packages need the new date format with year, month, and day. If you have only used month and year, how will decide what day is appropriate?
You must contract with an FDA-CDRH accredited agency to obtain the UDI information. To date, there are only three choices. Do you have criteria in place to help you make this supplier selection and document it under 820.50?
You will need at least two other suppliers, one to issue a DUNS number for your company and one to issue GMDN codes for your devices. Are you prepared to select these new suppliers and pay the fees?
For every device you sell, you must identify the data to populate the new database called GUDID. You will have to make decisions for about 50 data fields for every device! Do you know the extent of the data and have the resources in place?
You must load the data for all of your devices using either the FDA-CDRH web interface or HL7 information. Do you know the pros and cons of each method?
The cost for each session is only $425.00 per person. For two or more people from the same company in the same session, the cost per person goes down to $380.00. This affordable price allows you to bring team members. Each session runs from 9 a.m. to 4 p.m. and includes lunch and light refreshments during breaks.
For more information and registration, please contact Seminars@OmbuEnterprises.com.