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Monthly Archives: April 2017

Share on Google+ April 10, 2017

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American Preclinical Services Discusses Characterization of Extractables And Leachables: Challenges and Solutions

Category : APS Service Offerings, Our Laboratories

Chemical characterization of Extractables and Leachables (E&L) with the corresponding toxicological risk assessment are already mandated by regulatory agencies to ensure patient safety and successful submissions for medical devices. FDA regulations, USP and various ISO Standards namely 10993 part 18: Chemical Characterization of Materials, provide guidance to perform characterization of E&L. Extractables are compounds that are released from a device

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Share on Google+ April 3, 2017

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FDA CDRH Experiential Learning Program is open for comments

Category : FDA, Medical Device testing

The Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) announced on March 23, 2017 that the submission period for Experiential Learning Program (ELP) in open. ELP is a training component intended to provide CDRH staff with an opportunity to understand the policies, laboratory practices, patient perspective/input, quality system management, and other challenges that impact the device

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