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Infusion Pumps: FDA Emergency Use Authorization
The Food and Drug Administration (FDA) issues Emergency Use Authorizations (EUAs) in order to expand the availability of vitally important medical devices during the outbreak of the Coronavirus Disease 2019 (COVID-19)....
FDA Guidance:  Final Guidance on 3P510K
The Food and Drug Administration (FDA or the Agency), 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...