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Are Regulators the Root of the Problem of Serious Device Recalls?

Source link : https://www.newshealth.biz/health-news/are-regulators-the-root-of-the-problem-of-serious-device-recalls/

Among cardiovascular devices that were deemed unsafe enough to warrant urgent regulatory action, many had been allowed to skip rigorous premarket clinical testing in the first place, a report showed. Researchers identified 137 Class I recalls affecting 157 unique cardiovascular devices logged by the FDA from 2013 to 2022. Of these recalled devices, just 19.1% […]

Author : News Health

Publish date : 2024-09-16 21:00:00

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