Evidence of the tougher FDA stance expected from the new administration, reported here in a linked article, continues to mount as it reviews the previously allowed 510 K’s for Class 3 Devices. Although ordered by congress to become more stringent in approving Class 3 devices in 1990 the FDA has yet to implement the changes. Apparently hundreds of new class 3’s have been approved based on the 510 K requirement to prove substantial equivalence. Interestingly this equivalency can be proven by combining the characteristics of several different products. The issue is the always present tension between patient safety and cost since substantial equivalency can be proven in the laboratory which is much less costly than a clinical trial with human subjects. As a result as the new regulation is implemented a considerable number of devices may have to be retested with more costly clinical trials.
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