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FDA Approves First MDDTs FDA

FDA Approves First MDDTs

The Food and Drug Administration (FDA or the Agency), the US authority responsible for medical device regulation, announced amendments to the MDDT framework. Medical Device Development Tools (MDDT) The Agency published a notice dedicated to certain amendments made to...

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Health Canada announces REP Expansion Canada

Health Canada announces REP Expansion

The Health Products and Food Branch of Health Canada, the Canadian regulating authority in the sphere of medical devices, issued a notice on the expansion of the medical device Regulatory Enrolment Process (REP) pilot program. Regulatory Enrolment Process: Regulatory...

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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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