510(k) Changes: More bench testing and stricter design controls?

Le Chiffre

Quite Involved in Discussions
#1
If the findings of this study are taken into consideration:

http://www.qmed.com/news/22701/univ...wont-ensure-device-safety-study-fda-product-r

"A study of FDA product recalls shows that more clinical testing wouldn't prevent most problems."

"More clinical studies testing medical devices in humans probably wouldn't have prevented the pre-market problems behind most serious recalls. Instead, more bench testing and stricter design controls would appear to be more effective and more ethical"​
From my experience, compared to Health Canada, the FDA already focus more on bench test reports than clinical trials. Clinical trials are good for demonstrating the product working, bench tests are better for seeing where it will break!
 
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R

rclanzillotto

#2
Humans are not used to verify most device safety characteristics...so no surprise that more clinicals would not serve to prevent most recalls or adverse events. Device safety needs to have been demonstrated prior to entering into Clinical Trials.
 
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