FDA plan would speed up medical device approvals

Published April 22, 2014 2:40pm ET



WASHINGTON (AP) — The Food and Drug Administration unveiled a proposal Tuesday designed to speed up development and approval of medical devices that treat life-threatening diseases and debilitating conditions.

Under the Expedited Access Program, companies developing devices for critical and unmet medical needs would get earlier access to FDA staff to discuss their products. The agency says the earlier contact with regulators should result in “earlier access to safe and effective medical devices.”

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