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US Congress Targets FDA Premarket Reviews, Clinical Trials for Medical Devices

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Legislation advancing through both houses of the US Congress would require “least burdensome” training of Food and Drug Administration staff involved in premarket reviews of medical devices.

US FDA proposed legislation for least burdensome reviews, IRB centralization for medical devicesOriginally introduced in the US Senate last year, the FDA Device Accountability Act of 2015 would impact US regulators’ premarket review process as well as requirements for Institutional Review Boards (IRBs) that review clinical testing plans.

First, the bill would require medical device regulators at the FDA to train staff involved in premarket reviews are trained on least burdensome requirements necessary to demonstrate safety and effectiveness. FDA personnel would also have to periodically evaluate their implementation of these requirements and audit the training program.

Second, the bill would rescind requirements that IRBs that review device clinical testing plans are local to proposed testing facilities. Instead, clinical testing sponsors would be able to access a centralized IRB, which would prove particularly advantageous in instances where clinical trials are conducted at multiple sites in different locations.

Similar proposals are being considered in the US House of Representatives. Emergo will track the progress of these bills and provide further information on how US medical device market registrants will be impacted if they become law. 

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