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FDA Report Card 2015: Consistency


I used to hear a lot of complaints about consistency at FDA, but I don't hear them anymore. FDA vacillates in some areas of policy development, but that's not a bad thing. It just means that the agency is listening to the public and I applaud that.

—Bradley Merrill Thompson, shareholder, Epstein Becker & Green

Consistency is difficult to measure. Every medical device is different and every reviewer is different. Just like every employee in a company is different and no matter what 'systems' are in place, every person will perform their job differently. Most importantly, since every device is different, is consistency something we really want to have?

—Michael Drues, PhD, president, Vascular Sciences

It is difficult to confirm consistency in the absence of some credible and uniform measure of evaluation. However, review of the device Classification Type and responsible Division does support indications of discrepancies over time for the evaluation for device specific PMA and/or 510(k) submissions.

Larry R. Pilot, attorney at law


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