We hope you have some great plans for New Year’s Eve. Eat some cake, drink a glass of champagne and kiss that special someone at midnight. Then rest up over the long weekend because 2016 is going to mean a lot of work for the Class II device companies. Here are some things to keep in mind and put into practice when you land back in the office January 4.
- Start working toward UDI compliance immediately. The FDA’s September 24 compliance date for Class II device labelers might seem far away but there are only 185 working days for most U.S. companies in 2016 before the deadline.
- Do not underestimate the effort involved. UDI compliance involves many steps, new processes and systems, issuing agency and vendor selections, and much more.
- Involve the right people at every level. Your UDI team should include representatives from Compliance/RA, IT, Labeling, Legal, Supply Chain/Operations and perhaps others, depending on your company structure.
- Make sure your senior leadership is aware of the scope of the project for your company and you have executive buy-in and sponsorship from the beginning.
- Ask for help. For many companies, UDI compliance has too many moving parts to go it alone. Do not be afraid to ask for help from the experts. Reed Tech has submitted over 115,000 unique UDI records to the GUDID on behalf of our clients.
We wish you a very happy (and productive) 2016!