New FDA Unique Device Identifier System (UDI) launched today

In today’s Federal Register, the FDA has released a 44 page final rule initiating a new Unique Device Identifier System (UDI) for Medical Devices.  It will create a database of these identifiers called the GUDID, Global Unique Device Identification Database.  And it will require Medical Device manufacturer’s to both register their devices in the database and add the Unique Identifier Number to the labels of their products.

To help our customers understand this new rule, today we’ll discuss the goals of the new system, the Part 21 Sections of the Code of Federal Regulations that will be impacted and the dates by which Medical Device Manufacturers should be prepared to comply.  It is a rule that will have broad implications and should be reviewed by all MedDev developers and manufacturers here in the U.S.

First, why has the FDA created this database and registration system?  The FDA has a mandate to promote public health objectives, and one of the main objectives is to reduce medical errors.  Building upon the success of the use of electronic medical records, this program is intended to make device specific information readily available across the user community.

Additionally, the expectation is that having the source document information available directly from the manufacturer, the integration of device specific information will be made easier.  And again, the information gleaned by the electronic identification of devices can promote faster identification of problems with specific devices and solutions for problems that are reported.

Other safety concerns the FDA hopes will be promoted by the use of this electronic data are smoother product recalls, improved FDA communication of these types of safety problems, better dating of the devices themselves and so on.

This final rule affects the following Parts of 21 CFR, the Food and Drug Section of the Code of Federal Regulations:

• Part 16, Regulatory Hearing before the FDA
• Part 801, Labeling
• Part 803, Medical Device Reporting
• Part 806, Medical Devices – Reports of Corrections and Removals
• Part 810, Medical Device Recall Authority
• Part 814, Premarket Approval of Medical Devices
• Part 820, Quality System Regulation
• Part 821, Medical Device Tracking Requirements
• Part 822, Postmarket Surveillance
• Part 830, A new Part that has just been added to cover this new system

As you can see, this rule covers most of the critical areas of medical device compliance for FDA approval!

This new rule is effective December 23, 2013, except for the following sections: 801.55, 830.10, 830.100, 830.110, 830.120, and 830.130.  These Sections are effective October 23, 2013.  However, you’ll want to review section VII.B for compliance dates.  And here is a quick table that summarizes the compliance calendar: Compliance Dates for UDI Requirements.  The various types of devices have specific dates spelled out here which range from September 24, 2014 to September 24, 2018.  You may be required to submit a request for extension to have time to get your system in place.

Thursday, I’ll review the new Draft Guidance document for the GUDID system.  Even though it’s a draft, it may be very helpful to you in reviewing what you’ll need to actually do to meet these new requirements.

If you’d like a free pdf copy of the final rule, please contact my staff by email at info@document-center.com and mention today’s blog.  If you need other FDA guidance documents, or would like to have notifications of changes when new FDA documents are released, check in with us as well.

You can purchase the documents you need for FDA compliance and all your standards requirements at our web store, www.document-center.com.  Or contact us by phone (650-591-7600), fax (650-591-7617) or email as above.  We’re here to help you stay on top of the regulatory compliance documentation requirements you have — We’re your Standards Experts!