Regulatory Focus™ > News Articles > Report: FDA Developing UDI Barcode System for Medical Devices

Report: FDA Developing UDI Barcode System for Medical Devices

Posted 26 April 2012 | By Alexander Gaffney, RAC 

A report in The Wall Street Journal and The Gray Sheet indicate the US Food and Drug Administration (FDA) is working to develop and roll out a Unique Device Identification (UDI) system.

The policy-long in development and long held-up at the White House's Office of Management and Budget (OMB)-was mandated under the Food and Drug Administration Amendments Act (FDAAA) and is intended to standardize how medical devices are tracked.

FDA has been attempting to harmonize the development of the UDI system with international standards, and critics claim the lack of a rule is risking a divergence in international standards. The lack of a UDI rule has also led to legislators pressuring the agency through legislation, including the Drug Supply Chain Integrity Act, a modified version of which is included in Senate Health, Education, Labor and Pensions Committee's draft of the FDA Safety Improvement Act (FDASIA).

The issue has taken on increased importance in recent weeks as a series of safety issues involving St. Jude Medical, Medtronic and now Boston Scientific have been dragged into a safety debate involving their defibrillator products. FDA and Medtronic said as a result of the incident, they would be looking to make changes to their device surveillance procedures.

According to The Gray Sheet, FDA's Senior Advisor for Patient Safety, Jay Crowley, told the Association for Medical Diagnostics Manufacturers the agency would begin testing a UDI pilot next month in cooperation with medical device industry group AdvaMed.

"The purpose of the pilot really is to gain an understanding of whether this monstrosity that we built actually works, whether it makes sense, whether people can actually use it," Crowley said at the 19 April meeting.

The entire UDI system is scheduled to be launched January 2013 "regardless of the status of the UDI proposed rule, which is still under review at the Office of Management and Budget," reports The Gray Sheet.

That system will involve "a barcode-like number to search record databases," reports Fierce Medical Devices. "The goal is to allow the agency to determine the rate at which a device is failing."

"The system is designed to catch malfunctioning devices like [those sold by] St. Jude Medical Inc," reports The Wall Street Journal.

The system could be as launched as early as today (26 April), The Journal notes.

Read more:

The Wall Street Journal - FDA Plans ID-Tag System to Detect Faulty Devices

The Gray Sheet - UDI database testing

Fierce Medical Devices - FDA closer to unveiling barcode system as Senate panel blesses UFA

Regulatory Focus - As St. Jude Spat Escalates, FDA Looks to Additional Device Surveillance

Regulatory Focus - Politico: FDA Efforts to Create International Uniform Device Code Stalled by OMB

Regulatory Focus - Proposed FDA Rules for UDIs, Laser Products Continue to Languish at OMB

Regulatory Focus - Health Agency Releases Regulatory Agenda Update, Includes FDA Regulations in Development

Regulatory Focus - Bill Would Address Medical Device Safety By Giving FDA Additional Authority

Regulatory Focus - US Senate Drafts Substantial Changes to Drug Supply Chain Integrity, Medical Device Policies

Regulatory Focus - After Regulatory Issues Raised, Medtronic Plans to Heighten Postmarketing Safety Monitoring

Cardiovascular Business - Bos Sci now under fire for ICD-related patient death


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