FDA The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a final guidance document dedicated to the submission of 510(k) notifications for changes to medical devices that have already been...
FDA The Food and Drug Administration (FDA) has developed a guidance document dedicated to the benefit-risk factors to be considered when determining substantial equivalence in premarket notifications (510(k)) with different technological characteristics. The document is...
North America The Food and Drug Administration, the US authority responsible for medical device regulation, issued guidance dedicated to the Third Party (3P510k) Review Program allowing recognized third parties to perform the review of premarket notification submissions filed by...
North America The Food and Drug Administration, the US authority responsible for medical device regulation, issued guidance dedicated to premarket notification 510(k) submissions for bone anchor devices. Bone Anchor: General Approaches The new guidance issued by the US regulating...
North America The US Food and Drug Administration (FDA), the authority responsible for medical device regulations, issued guidance dedicated to recommendations for Dual 510(k) and CLIA Waivers by application pathway. CLIA Waiver: Brief Overview The document describes in detail...
