Preparing for FDA's Unique Device Identification Rule

This 90-minute webinar will review FDA's draft regulations for UDI and describe the new requirements for labeling medical devices. It covers the new regulations in 21 CFR Part 830, the changes to Part 820, the Quality System Regulation; Part 801, Labeling; Part 803, Medical Device Reporting; Part 806 Corrections and Removals; and other regulations.

Why Should You Attend:

In July 2012, the FDA issued the draft regulations for Unique Device Identification (UDI). This draft regulation describes new requirements of labeling medical devices as well as providing information to a new database that FDA maintains.

This webinar explores the explicit requirements as well as the hidden requirements in the draft UDI regulation.

Your Quality Management System (QMS) should be able to address these questions quickly and easily. If not, then your team needs to attend this webinar!

Do you know what needs to be on a label today and how the draft UDI regulation will change the label?

If you ship a device in packages of 1, 5, 10, and 25, will you be able to mark each package with only one UDI?

Do you know who will issue the unique code for your device? If you think it is FDA, you may be surprised!

Can you state the fixed and variable elements that need to be on your device label?

Do you know the correct format for a date?

Is it true or false that FDA will require you to use only 2D barcodes?

Can you put the marking on the label only? Does it have to be on the device?

What is the responsibility for the designated person to inform the FDA of each code?

Will you need a GMDN code for your device? What is a GMDN code?

Areas Covered in the Webinar:

• An explanation of the draft regulation.
• When a UDI is required
• What is on a label
• What is in the new FDA database

A description of the changes to the device regulations

• New Part 830 on Unique Device Identification
• Part 801 on Labeling
• Part 803 on Medical Device Reports
• Part 806 on Corrections and Removals
• Part 807 on Registration and Listing
• Part 820 on the Quality Management System
• Part 821 on Device Tracking

An analysis of the “hidden” requirements

• Will a new UDI require a design change
• When will a new UDI trigger a new 510(k) and vice versa
• When does an update to the DMR require a new UDI

Implementation Recommendations

• Integrating requirements
• Many small changes touch the whole system

Inspections

• What can we expect FDA Inspectors to look for
• How could Inspectors compare UDI, device listing, MDRs, and recalls
• Will FDA have the potential for data mining before the inspection

Who Will Benefit:

This webinar is for people involved in understanding, analyzing, and implementing the UDI regulations.

People in the following roles can especially benefit from the knowledge in this webinar:

• Quality Managers
• Quality Professionals
• Production Managers
• Production Supervisors
• Manufacturing Engineers
• Production Engineers
• Design Engineers
• Process Owners
• Device Labeling and Packaging Companies