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FDA expands its internal program to learn more from companies about medical device manufacturing

The Food and Drug Administration is expanding its Experiential Learning Program, with aims to learn more about the manufacture medical technologies – particularly in vitro diagnostics and next-gen sequencing, RAPS reports. A new notice says that FDA’s learning program will expand into 34 areas of interest – including understanding the manufacturing process of continuous glucose monitors, insulin pumps, mass […]

By Meghana Keshavan on April 09, 2015

The Food and Drug Administration is expanding its Experiential Learning Program, with aims to learn more about the manufacture medical technologies – particularly in vitro diagnostics and next-gen sequencing, RAPS reports.

A new notice says that FDA’s learning program will expand into 34 areas of interest – including understanding the manufacturing process of continuous glucose monitors, insulin pumps, mass spectrometry and assay development.

The program was first proposed in September 2011, so that FDA regulators can learn more about the cutting-edge technologies they are currently or will soon regulate. FDA officials can attend “formal training visits” at industry sites, RAPS says. Companies participate on a voluntary basis – no inspection or actual regulatory work goes on here. It was launched by the FDA’s Center for Devices and Radiological Health.

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“We are investing resources so that new device reviewers at CDRH are equipped to handle the range of issues that arise during the premarket device reviews,” CDRH Director Jeffrey Shuren said in a 2011 statement. “This investment will improve the quality of submission review and make the process more consistent and predictable.”