FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has developed a guidance document dedicated to Pre-Requests for Designation (Pre-RFD). The document describes the approach to be applied by...
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices and other healthcare products, has published a guidance document describing how to write a Request for Designation (RFD). The document is intended to...
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published detailed guidance dedicated to the types of communication during the review of medical device submissions. The document is intended to...
FDA
The Food and Drugs Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published a guidance document dedicated to the eCopy Program for medical device submission. The present document constitutes an updated version of...
FDA
The Food and Drug Administration (FDA) has developed a guidance document dedicated to the benefit-risk factors to be considered when determining substantial equivalence in premarket notifications (510(k)) with different technological characteristics. The document is...
FDA
The Food and Drug Administration (FDA) has published an information sheet guidance describing the regulatory aspects related to the Significant Risk and Nonsignificant Risk medical device studies. The document is intended to provide additional clarifications and...
