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November 2012

Greg Davis

Six Costly Mistakes that Start-Up CEOs Should Avoid When Launching Medical Devices in Europe

by Greg Davis
Founder & CEO, Med Celerate

Representing one-third of the global medical device market, the European Union provides a significant opportunity for start-up medical device companies. But, it can also present costly challenges for the unprepared. Following are a half-dozen cautions drawn from real-world experience that could help you avoid the most common commercial pitfalls.

What are the strategic reasons for launching your product in Europe? Our experience has validated more than 10 unique objectives, ranging from driving rapid revenue growth to providing product free of charge. Expecting rapid revenue growth, premium pricing, and deep account penetration simultaneously leads to frustration and disappointment. Analyze your strategic options, understand financial implications, and stay laser-focused on what's most important.

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Pamela ForrestElaine TsengSteven Niedelman

FDASIA: Key Statutory Changes for Medical
Device Companies

by Pamela F. Forrest, Elaine H. Tseng and Steven Niedelman
King & Spaldings FDA/Life Sciences Practice Group

The Food and Drug Administration Safety and Innovation Act (FDASIA), enacted July 9, 2012, is the most recent statute impacting FDA's regulation of medical devices. FDASIA is significant not only because it reauthorizes user fees for device submissions, in exchange for FDA's commitment to achieve certain performance goals in the review of those submissions, but also because it institutes various other changes to the device regulatory framework. Several of these should or may benefit medical device companies, while the impact of others is less apparent. We discuss certain key FDASIA provisions below.

FDASIA reauthorizes the collection of user fees from device companies for fiscal years (FYs) 2013 - 2017. As before FDASIA, fees increase each year. Fee types remain unchanged; however, there is a significant increase in entities that must pay establishment registration fees. Previously, these applied to manufacturers, specification developers, and single-use device reprocessors only; under FDASIA, registration fees now apply to any facility "engaged in the manufacture, preparation, propagation, compounding, or processing of a device." Among others, this includes contract manufacturers, packagers, and sterilizers (whether or not they commercially distribute devices), as well as establishments that maintain device complaint files only.

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FDA Compliance Officer: Industry, FDA Must Focus on Device Quality (Not Just Compliance)

by Arundhati Parmar

Complying with regulation so that device makers avoid being slapped on the wrist by the U.S. Food and Drug Administration is a narrow effort compared with building high-quality devices that meet the needs of patients.

That's the distinction that Steve Silverman, FDA's top compliance officer when it comes to devices, made at a speech to a Minneapolis audience on Monday night.

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Did you know that the FDA has a plan to improve response times for 510(k) applications? The plan, a part of the latest user-fee agreement, will help roll out a process for speeding up the time it takes to review and approve new devices.
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