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FDA Template for Home Collection Kits FDA

FDA Template for Home Collection Kits

The Food and Drug Administration (FDA), the United States’ authority for medical devices regulation, issued home specimen collection molecular diagnostic template in order to provide medical device manufacturers with the recommendations related to the content of...

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FDA Guidance on Supplements for PMA and HDE Submissions FDA

FDA: Final Guidance on 3P510K

The Food and Drug Administration (FDA), the US authority responsible for medical devices regulation, has recently published a transcript of the final guidance dedicated to the 510(k) Third Party Review Program (3P510K). The document follows the initial guidance on...

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