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The Food and Drug Administration (FDA) has published amended draft guidance on electromagnetic compatibility (EMC) of medical devices. The Agency encourages the industry representatives and other parties involved in operations with medical devices to provide their...
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 Notes The present document constitutes a final version of the draft guidance issued previously in September 2017....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...
FDA
The Food and Drug Administration (FDA), the US regulating authority, has updated the information materials dedicated to importing and exporting medical devices. Importing and Exporting: the Basics According to the general rule, the entity involved in the...
