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FDA Draft Guidance for Medical Devices Prepares for End of Pandemic

USA - March 16 2022 The FDA has issued two separate draft guidance documents for medical devices being marketed subject to 1) an Emergency Use Authorization…

FDA Proposes to Harmonize Medical Device Quality System Regulations With ISO 13485

USA - March 15 2022 The FDA has published a proposed rule to align its medical device quality system regulations with the ISO 13485 quality system The rule…

FDA Issues Final Guidance on Third-Party Review of 510(K) Applications

USA - March 17 2020 The FDA recently released a final guidance, titled “510(k) Third Party Review Program” and known as 3P510k, discussing the factors the FDA uses to…

FDA Finalizes Clinical Laboratory Guidance Documents for In Vitro Diagnostic Tests

USA - March 3 2020 The FDA recently released two final guidance documents that provide recommendations for Clinical Laboratory Improvement Amendment (CLIA) waivers -…

FDA Launches Limited Pilot Program for Interactive 510(K) Application

USA - March 2 2020 The Food and Drug Administration (FDA) recently announced that it is soliciting participation for its voluntary Electronic Submission Template and…