GxP Lifeline Newsletter
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August | 2017
MasterControl GxP Lifeline

Nuts and Bolts of 510(K) Submissions
by Rob Packard, President, Medical Device Academy, Inc.


A 510(k) is pre-market notification of medical devices to the US FDA. The number “510” refers to section of the Food, Drug and Cosmetic Act. “k” is the subsection specific to pre-market notification. Details regulating the process, however, are found in 21 CFR §807.



Regulatory Strategies for AI and Emerging Technologies
by Steve Tyrell and Lisa L. Michels, Regulatory Compliance Associates Inc.


When powerful new technologies emerge, unbridled excitement often reigns. The possibilities are endless and markets are undoubtedly huge. Artificial intelligence and machine learning in medicine are at an early stage and the potential to improve medical care is solidifying.



6 Opportunities and Challenges Combo Product Makers Should Be Aware of in 2017
by Alex Butler, Manager, Medical Device Solutions, MasterControl


Thanks to constant leaps in scientific and technological innovation in recent years, we’re witnessing a steady (and very promising) trend toward combination products – those that merge two or more different types of regulated drugs, medical devices or biologics into one multi-faceted treatment.


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10 Most Common Reasons for FDA 483 Inspectional Observations and Warning Letter Citations in Medical Device Environments
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Transitioning from the Medical Device Directives (MDD) to the Medical Device Regulation (MDR)
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5 Reasons Why Big Medtech Companies Struggle to Innovate

Is The 510(k) Process As Worthless As The Federal Courts Seem to Believe?
by Jeffrey K. Shapiro, Hyman, Phelps, McNamara, P.C.


Does the Food and Drug Administration’s review of medical devices in the 510(k) program involve a substantial review of safety and effectiveness? FDA says it does (p. 44). Device makers and those of us who practice in this area know how burdensome and extensive this process can be. It requires device makers to provide extensive preclinical safety and effectiveness data for FDA’s review.



UDI as Med Device Product Tracking Software (Why That’s a Good Thing)
by Cindy Fazzi, MasterControl Staff Writer


When the U.S. Food and Drug Administration (FDA) mandated the use of unique device identification or identifier (UDI), some people voiced concerns over the high cost of the requirement, as well as the technology challenges it posed. What is UDI and why is it important?


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