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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
- 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
Dan, is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.
UDI is the first major change to many of the implementing regulations in recent years. While the draft is still in the comment period, it is very unlikely that it will undergo significant changes before the final regulation. Congress passed legislation in 2007 directing the FDA to develop unique device identification for medical devices. In June 2012, Congress passed another law directing the FDA to publish a draft rule by the end of 2012, publish the final rule no later than 6 months after the close of the comment period, and implement the final regulations for specified devices within two years.
The draft UDI regulations will require major changes for device manufacturers. You must change your quality management system for the new requirements. These changes fall into two categories.
In the first category, you will implement specific, but broad based, requirements for the UDI system. These will include, but extend far beyond, Part 820. For example, you will implement the new Part 830, revise your medical device reporting procedure, update your corrections and removals procedures, and change your design control, labeling, device master record, device history record, and complaint procedures.
In the second category, you will implement specific, but narrow requirements for each device and packaging level. For example, if, today, you decide to ship product in packages of five, you do not have to inform FDA, the listing doesn’t change. However, the same new packaging will create a new UDI at the packaging level, so you must inform FDA!
While the regulation appears simple on the surface, but there are many potential problems and traps. It appears you will just change the device label by adding new information and provide some data to FDA for their new database. However, you will need a new UDI for each packaging level. A device will have a UDI, but each packaging level needs a new UDI; a package of one has a different UDI than a package of five!
Moreover, the UDI must change when the device design changes, there is a new indication for use and, potentially, for each change in the Device Master Record. You will need to evaluate each change to see if it creates a new version or model; each one requires a new UDI. If you change any of the following, you need a new UDI:
- The specifications, performance, size, or composition of the device to an extent greater than the specified limits
- The quantity in a device package or add a new device package
- Significantly affect the safety or effectiveness of the device
- From a nonsterile package to a sterile package or vice versa
- Relabel the device
Successful manufacturers will quickly integrate the new UDI regulations into their existing programs. Because of the benefits to certain customer, early adopters can gain a competitive advantage. You need to start planning now for the new regulation. For example, the changes in labeling will require new responsibilities for the designated individual who verifies the labels. Less obvious is the change in design input. Manufacturers may need to invoke the design change requirements, 820.30(i), to implement the new UDI requirements; the device label will have major changes!
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Daniel O Leary
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