FDA In Brief: FDA launches new interactive, PDF-based, template to promote greater efficiency and consistency in preparation and review of 510(k) medical device applications

https://www.fda.gov/news-events/fda-brief/fda-brief-fda-launches-new-interactive-pdf-based-template-promote-greater-efficiency-and-consistency?utm_campaign=022620_FIB_FDA%20launches%20new%20interactive%2C%20PDF-based%2C%20510%28k%29%20submission%20template&utm_medium=email&utm_source=Eloqua

FDA In Brief: FDA launches new interactive, PDF-based, template to promote greater efficiency and consistency in preparation and review of 510(k) medical device applications

The following quote is attributed to Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health:

As technology advances, the FDA must keep pace with the increasing complexity of rapidly developing technology and continue to modernize and evaluate our programs and processes, ensuring they continue to be efficient, consistent and scientifically rigorous. “To promote these goals, we’re launching a new optional 510(k) submission template that allows pilot participants to submit applications to the FDA using a more dynamic electronic format capable of organizing the complex information necessary for a robust scientific review. Without changing our statutory or data requirements, this highly-interactive submission template is intended to allow manufacturers to provide information to the FDA that’s complementary to ..."

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