FDA The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices and healthcare products, has published detailed guidance dedicated to audits in the context of the Medical Device Single Audit Program (MDSAP). ...
FDA The Food and Drug Administration (FDA), the US regulating authority in the sphere of medical devices has published final guidance on labeling requirements for laparoscopic power morcellators. The present document constitutes a final version of the appropriate guidance...
FDA The Food and Drug Administration (FDA), the US regulating authority in the sphere of medical devices, has published several guidance documents addressing product-specific performance criteria for certain types of medical devices, including spinal plating systems and...
FDA The Food and Drug Administration (FDA), the US regulating authority in the sphere of medical devices, has published a transcript of the virtual town hall dedicated to the guidance on Coronavirus (COVID-19) diagnostic tests issued earlier by the Agency. The conference...
FDA The Food and Drug Administration (FDA), the US regulating authority in the sphere of medical devices, has published a discussion paper dedicated to the proposed regulatory framework for modifications to the software as a medical device (SaMD) based on the artificial...
FDA The Food and Drug Administration (FDA) has published guidance dedicated to requesting FDA feedback on combination products. The document is intended to improve the clarity and transparency of the existing regulatory framework for combination products. Due to its legal...
