Extending COVID-19 Policy, FDA Says PMA, HDE Supplements Are Not Needed for Some Device Changes

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Extending COVID-19 Policy, FDA Says PMA, HDE Supplements Are Not Needed for Some Device Changes

Dennis Tosh

November 2, 2023 at 12:34 PM EST

The FDA says that it will not object to a medical device manufacturer making certain changes to a device that has an approved premarket approval (PMA) application or an approved humanitarian device exemption (HDE) without providing supplemental submissions to the agency where the changes do not affect the safety or effectiveness of the device and are made to address manufactur... Read More

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Extending COVID-19 Policy, FDA Says PMA, HDE Supplements Are Not Needed for Some Device Changes

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