News - UDI

The countdown is on. Pharmaceutical companies doing business in the United States have less than four years to implement the requirements of a federal track and trace law. The law is part of the Drug Quality and Security Act that was signed into law by President Obama on November 27.

The Drug Quality and Security Act requires pharmaceutical companies to adopt a track and trace system for their medicines. Individual packs of drugs will need serial numbers by November 27, 2017. In 10 years, medicine will need to be traceable as it makes its way from the manufacturer to a pharmacy.

The law also creates stricter license requirements for distributors and third parties who transport drugs. The FDA will also maintain a database of wholesalers that will be available to the public through its website.

Federal track and trace requirements will replace similar state laws. In fact, California’s ePedigree law was set to take effect on January 1, 2015. The federal law gives pharmaceutical companies more time to comply with trace and trace legislation.

Pharmaceutical companies need to develop a strategy to conform to the Drug Quality and Security Act.

USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet the regulations. Our team of experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made.

Read More About USDM's Unique Device Identification and Track and Trace Services

 

USDM Life Sciences continues to expand its regulatory compliance services and solutions. Jay Crowley, the architect of the FDA’s UDI Final Rule became the Vice President of the UDI Practice at USDM Life Sciences in January. Grant Hodgkins, former Head of Global Data Management at Alcon Labs was hired as Vice President of the company’s Commercial Practice in April.

Pharmaceutical Commerce recently published a news article about the expansion of USDM’s regulatory compliance team.  Click here to read USDM Hires Serialization, UDI Heavyweights to Build a Strategic Consulting Practice.

 

The developer of the FDA's Unique Device Identification system was just hired by USDM Life Sciences.

Jay Crowley is the Vice President of the Unique Device Identification practice. In his new role, Crowley will help USDM Life Sciences clients with UDI compliance.

Crowley was most recently Senior Advisor for Patient Safety in the Food and Drug Administration's Center for Devices and Radiological Health. Crowley developed the framework and authored key requirements for the FDA's Unique Device Identification system.  Crowley served various roles at the FDA for 27 years.

 

View Press Release

China plans to have a Unique Device Identification (UDI) system in place by the end of the year, according to a report in The Gray Sheet.

The Vice President of the UDI Practice at USDM Life Sciences, Jay Crowley, was interviewed for the article. Crowley was the architect of FDA's UDI regulations. In the article, Crowley discusses the problems FDA was trying to solve with the development of a UDI system in the United States. He also discusses what some of the medical device identification issues are in China.

The goals of UDI are to prove the authenticity of medical devices and be able to identify exactly which device, including version of components and software, is in the hands of a patient or medical facility.

Here is a link to the article. You need to be a subscriber or register for a free trial to The Gray Sheet to view the article.

As Vice President of the UDI Practice at USDM Life Sciences, Crowley helps medical device manufacturers achieve regulatory compliance as well as internal benefits and competitive advantage with UDI implementation.

Most contact and intraocular lens labelers now have an extra year to become compliant with the FDA’s Unique Device Identification (UDI) Final Rule.  The new compliance date is September 24, 2015.

The FDA changed the UDI compliance deadline after lens manufacturers said there would be a tremendous amount of submissions to the Global UDI Database (GUDID), and because many submissions will be virtually identical. 

See the FDA's letter to contact lens manufacturers below:

 

Dear Class III Contact Lens and Intraocular Lens Labelers:

Effective August 15, 2014, the FDA’s Center for Devices and Radiological Health (CDRH) is granting a 1-year extension of the September 24, 2014 Unique Device Identification System (UDI) compliance date for the following class III medical devices:

DeviceProduct CodeClassification Regulation
Rigid Gas Permeable Contact Lens (extended wear) MWL 21 CFR 886.5916(b)(2)
Orthokeratology Contact Lens
(Overnight)
NUU
Soft (hydrophilic) Contact Lens
(extended wear)
LPM 21 CFR 886.5925(b)(2)
Intraocular lens (IOL) HQL 21 CFR 886.3600
Multifocal Intraocular lens MFK
Accommodative Intraocular lens NAA
Toric Optics Intraocular lens MJP
Phakic Intraocular Lens MTA  
Iris Reconstruction Lens NIZ  

On September 24, 2013, the FDA published a final rule establishing a unique device identification system (the UDI Rule). The UDI Rule outlines labeling, data submission and standard date formatting requirements for all medical devices in commercial distribution in the U.S., unless an exception or alternative applies. The rule will be phased in over a 7-year period through an established set of compliance dates. The compliance date for class III devices is September 24, 2014. Recently, certain labelers of the contact lens and IOL industries notified the FDA of a UDI labeling strategy being employed for these devices that would result in an extremely large number of data submissions to the Global Unique Device Identification Database (GUDID). Not only would the volume of submissions greatly exceed the best estimates previously available to the FDA, we have also learned that many of these submissions would be virtually identical files. Pursuant to 21 CFR 801.55(d), the FDA has determined that initiating and granting a 1-year extension would be in the best interest of the public health. This additional time will allow the FDA to work with the affected labelers to develop an approach to ensure that meaningful data will be submitted to the GUDID.

Therefore, labelers of devices listed above are now provided a new UDI compliance date of September 24, 2015. The extension applies to the requirements to provide a UDI on the device label and packages, format dates on the device label according to 21 CFR 801.18, and submit data to the GUDID. Some labelers may have already implemented the UDI label and date format requirements for these devices. In such cases, this extension would only apply to the requirement to submit information to the GUDID.

For additional information, please contact the FDA UDI Help Desk.

Sincerely yours,

Thomas P. Gross, MD, MPH
Director
Office of Surveillance and Biometrics
Center for Devices and Radiological Health
Food and Drug Administration

USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet UDI regulations. Our team of UDI experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM’s assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to the GUDID.

 

The FDA’s Center for Devices and Radiological Health (CDRH) is granting a compliance extension of some of the UDI labeling requirements for some non-sterile implantable medical devices, which were otherwise subject to the September 24, 2015 compliance deadline.The new compliance deadline is September 24, 2016 for devices that meet ALL of the following criteria:

Compliance Deadline Extension Criteria

  1. Classified with primary product codes and regulations listed on the letter to implant labelers
  2. Single use implants, and
  3. Intended to be sterilized (or cleaned and sterilized) before use. Most of the devices that meet these three criteria are supplied non-sterile by the manufacturer

 

USDM Life Sciences will provide more details about the extension at a live webinar on January 14, 2015. USDM’s Jay Crowley, who had primary responsibility for the development and implementation of FDA’s UDI system will lead the presentation.

USDM Life Sciences continues to help medical device manufacturers with Unique Device Identification (UDI) compliance. Jay Crowley, the architect of the FDA’s UDI Final Rule is now Vice President of UDI Services and Solutions at USDM. 

Medical Device and Diagnostic Industry recently interviewed Crowley for a news article about some of the challenges medical device manufacturers are facing with UDI compliance.  Click here to read the article "What to Expect When Implementing UDI."

Don’t miss the global unveiling of the new UDI Connect App at the UDI Conference.

If you haven’t already registered for the conference, here is a special discount code for you. Discount code: USDM

Join our Session on Thursday

The Challenges and Opportunities of UDI Implementation
Thursday, June 25 at 3:45pm

Jay Crowley will discuss how the successful and efficient implementation of UDI requires understanding of how your organization currently manages device identification and distribution and how it may mean modifying some parts of your infrastructure.

Jay Crowley is the Vice President of Unique Device Identification Solutions and Services at USDM Life Sciences.

Jay was most recently Senior Advisor for Patient Safety in the Food and Drug Administration’s Center for Devices and Radiological Health. Jay developed the framework and authored key requirements for FDA’s UDI system.

At USDM Life Sciences, Jay focuses exclusively on providing business process, technology and compliance solutions for the regulated life science industry.

The UDI Conference is June 24 & 25, 2015 at the Hilton Baltimore in Baltimore, MD

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