Real time review of premarket approval (PMA) supplements succeeds:
This article was originally published in Clinica
Executive Summary
By the end of March, medical device companies in the US should have been notified that the six divisions of the Office of Device Evaluation will conduct a "real time" review of those supplemental PMAs which do not constitute a high risk. During a pilot study, assessment of the submissions took fewer than five days for the 24 cases that the CDRH accepted for real time review, said Susan Alpert, head of the ODE.