Featured Product
This Week in Quality Digest Live
FDA Compliance Features
Dario Lirio
Modernization is critical to enhance patient experience and boost clinical trial productivity
Alexander Khomich
Healthcare software opens up opportunities for clinics in both management and patient care
Gary Shorter
Pharma needs to adapt and evolve with the changing environment of life science data
Etienne Nichols
Quality management system regulation explained
The short answer: Standard weights, rigorous procedures, and state inspectors ensure measurements are fair and accurate

More Features

FDA Compliance News
First trial module of learning tool focuses on ISO 9001 and is available now
Free education source for global medical device community
Good quality is adding an average of 11 percent to organizations’ revenue growth
Further enhances change management capabilities
Creates adaptive system for managing product development and post-market quality for devices with software elements
VQIP allows for expedited review and importation for approved applicants that demonstrate safe supply chains
An invite from Alcon Laboratories
Intended to harmonize domestic and international requirements
Pharma quality teams will have performance-oriented objectives as well as regulatory compliance goals

More News

Michael Causey

FDA Compliance

FDA Moves UDI Initiative Further Down the Production Line

The agency gets this one right

Published: Thursday, June 25, 2015 - 14:26

We, and others, like to take the FDA to task for missing deadlines or behaving in ways that are sometimes difficult to fathom. So it’s only fair to give equal space to something when they seem to get it right. Take the agency’s Unique Device Identification System (UDI).

Readers of this column might have different experiences with it—and we’d like to hear about them, good or bad—but you’ve got to tip your hat to the FDA because they’re trying to get this one right.

Last month, the FDA launched the Global Unique Device Identification Database (GUDID), a searchable website containing a listing of all UDIs. From industry as well as the agency, expectations are high for this system, which was implemented to simplify the identification of many regulated medical devices used by patients in the United States.

The complex infrastructure, which will be phased in over several years marked by a variety of deadlines that began in 2014 and are slated to wrap up in 2020, offers a number of potential benefits, including:
• Speeding and improving the accuracy of the reporting, reviewing, and analyzing of an adverse event.
• A quicker means to identify a device and extract important information about it.
• Enhancing analysis of devices on the market by providing a standard and clear way to document device use in electronic health records, clinical information systems, claim data sources, and registries. A more robust postmarket surveillance system can also be leveraged to support premarket approval or clearance of new devices and new uses of currently marketed devices.

Ultimately, the FDA hopes its UDI can become a worldwide model, too.

It’s worth noting that the FDA’s former point man for the initiative, Jay Crowley, continues to lead the bandwagon now that he’s ensconced in private practice with USDM Life Sciences. He’s led several webinars and given a number of talks that make a persuasive case for the positive effect UDI will have on the device industry. Sometimes, former FDA personnel spend the next ten years of their careers criticizing the very program they led. This is not the case with Crowley and that bodes well for UDI.

First published June 10, 2015, on the AssurX blog.


About The Author

Michael Causey’s picture

Michael Causey

James Michael Causey’s been a journalist since he started his own neighborhood newspaper in the 1970s. In addition to quizzing FDA officials for the past 10+ years, he’s also interviewed political satirist Art Buchwald, FCC Chairman Reed Hundt, SEC Chairwoman Mary Schapiro, and is the past president of the Washington Independent Writers. Causey is the editor and publisher of eDataIntegrityReport.com and is a contributing writer on the AssurXblog.