US FDA criticised over application handling:
This article was originally published in Clinica
Executive Summary
Citizens for a Sound Economy Foundation, a business-oriented public policy group, last week criticised the US FDA for its handling of medical device PMA applications. The group noted that, in fiscal 1996, the FDA approved 43 PMA applications with an average review time of 789 days, nearly four-and-a-half times the legal requirement. CSEF, a vocal advocate for FDA reform, also believes the agency could improve its processing of 510(k) notifications.
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