United States
The Association for the Advancement of Medical Instrumentation (AAMI) has published a Consensus Report intended to provide guidance regarding the safety-related aspects to be considered by the medical device manufacturers in the context of the Emergency Use...
FDA
The US Food and Drug Administration (FDA) has issued a guidance dedicated to the benefit-risk factors to be considered in the context of product availability, compliance, and enforcement decisions with regard to the medical devices. Notes The document describes the...
FDA
The Food and Drug Administration (FDA) has published guidance on certificates of confidentiality. The document is intended to provide additional clarifications to study sponsors, investigators, researchers, and other industry representatives. All interested parties...
FDA
The Food And Drug Administration (FDA), the US regulating authority in the sphere of medical devices, has published guidance on micro-needling products. Notes The present document constitutes a final version of the draft guidance issued previously in September 2017....
FDA
The Food And Drug Administration (FDA), the US regulating authority in the sphere of medical devices, has published a guidance document describing the process related to requesting a review of the FDA`s decision not to issue certain export certificates for medical...
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