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FDA Guidance on Ventilators and Accessories
The Food and Drug Administration (FDA or the Agency), the US authority responsible for medical device regulation, issued guidance describing an enforcement policy for ventilators, accessories and other respiratory...
Conformity Assessment Guidance from the IMDRF
The International Medical Device Regulators Forum (IMDRF), a voluntary association of medical device regulating authorities focused at the improvement and harmonization of the regulatory framework, issued guidance...
FDA Remote Auditing Pilot Program
The Food and Drug Administration (FDA), the US authority responsible for medical devices regulation, issued a policy on the Remote Auditing Pilot Program which would be implemented in the course of the Medical Device...
Monitoring Devices: A New FDA Policy
The Food and Drug Administration (FDA), the US authority responsible for medical devices regulation, issued guidance dedicated to enforcement policy for non-invasive remote monitoring devices used to support patient...