Source: http://www.complianceonline.com/preparing-for-fda-unique-device-identification-rule-webinar-training-702594-prdw
Timestamp: 2015-07-31 13:22:27
Document Index: 605350175

Matched Legal Cases: ['art 830', 'art 820', 'art 801', 'art 803', 'art 806', 'art 830', 'art 801', 'art 803', 'art 806', 'art 807', 'art 820', 'art 821', 'art 820', 'art 830']

FDA's Regulation of Unique Device Identification (UDI) – New Device Labeling Requirements : Compliance Training Webinar (Online Seminar) - ComplianceOnline.com
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.
Product ID: 702594
Course "Preparing for FDA's Unique Device Identification Rule" has been pre-approved by RAPS as eligible for up to 1.5 RAC credits towards a participant's RAC recertification upon full completion.
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.
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?
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
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
This webinar is for people involved in understanding, analyzing, and implementing the UDI regulations.
Device Labeling and Packaging Companies
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!