U.S. medical device regulator to improve PMA, IDE processes

U.S. medical device regulator to improve PMA, IDE processes-massdevice: The US Food and Drug Administration's Center for Devices and Radiological Health (CDRH) plans revisions to its Investigational Device Exemption process to improve clinical trial management for manufacturers and sponsors, and may also consider down-classifying some devices from Class III Premarket Approval registration requirements.