Understanding the Premarket Approval (PMA) Process: A Comprehensive Guide for Medical Device Innovators from Patrick Gora of Rochester
Innovators in the medical device industry often face a challenging regulatory landscape, especially when navigating the Premarket Approval (PMA) process. PMA is a stringent regulatory pathway designed by the U.S. Food and Drug Administration (FDA) to ensure that high-risk medical devices are safe and effective before they reach the market. Patrick Gora of Rochester provides […]
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