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UDI Exceptions, Exemptions and Extensions


UDI Exceptions, Exemptions and Extensions

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As the September 24 deadline approaches, a growing number of Class II labelers have been asking whether their devices might be somehow exempt from UDI requirements, or if at the FDA might grant them an extension. Unfortunately, while certain devices are exempt from UDI and the FDA has allowed extensions in rare situations, for most […]

A Risk-Based Approach to UDI Compliance

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As medical device manufacturers scramble to meet Unique Device Identification (UDI) deadlines, a risk-based approach to UDI compliance will help ensure continuity within the quality system, consistency in UDI practice and application, accuracy of the associated data and sustainability of the UDI process. But what is a risk-based approach and how does it apply to […]

Lessons Learned: GUDID Submissions

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Reed Tech subject matter experts recently attended a number of industry trade events where they received additional information and clarification from FDA on GUDID submissions. As you may be aware, Class III medical device labelers must submit the required UDI data attributes to FDA by September 24, 2014. Regardless of submission option chosen, FDA requires […]

Protecting Incentives to Innovate while Addressing Healthcare Costs

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In a previous blog post, we reviewed key factors that drive the research, development, and pricing of prescription drugs. Drug research is extremely expensive and yields only about one successful medication for every 20 candidates in development. Those medications then have a limited period of patent protection in which to earn back the cost of that […]

Drug Companies Facing ‘Patent Cliff’

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Baseball players are sometimes used to illustrate the elusive nature of success. Players who maintain a batting average of .300 throughout their careers – meaning they failed to get a hit 70 percent of the time – often are named to the sport’s hall of fame. If the pharmaceutical industry enjoyed a similarly lofty rate […]

GUDID Submission Methods for Medical Device UDI

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While medical device manufacturers prepare to comply with the new Unique Device Identification (UDI) requirements, the Food and Drug Administration (FDA) is preparing to introduce a powerful new industry and consumer resource that utilizes all that data: the Global Unique Device Identification Database, or GUDID.