FDA To Design Pilot Program for Assessing Device Conformance with Recognized Consensus Standards

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FDA To Design Pilot Program for Assessing Device Conformance with Recognized Consensus Standards

Using Test Laboratories To Evaluate Devices According to Standards Will Ease Sponsors’ Regulatory Burden, Agency Says

Dennis Tosh

Guide to Medical Device Regulation

May 16, 2017 at 04:55 AM EST

The FDA is beginning to establish a system through which accredited test laboratories could determine a medical device’s conformance with recognized consensus standards. The initiative could help device sponsors speed their products to market by including in their premarket submissions to the agency a determination by an accredited laboratory that a device conforms with the s... Read More

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FDA To Design Pilot Program for Assessing Device Conformance with Recognized Consensus Standards

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