FDA
The new article addresses aspects related to some specific types of requests, and also provides a checklist to be used by the authority when assessing the requests for feedback. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating...
FDA
The new article addresses aspects related to non-clinical performance testing for patient-matched guides. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulatory authority in the sphere of healthcare products, has published a guidance...
FDA
The new article addresses aspects related to submission issue requests as a specific type of submission under the Q-Submission program. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare...
FDA
The new article addresses aspects related to information regarding sterilization methods the authority expects medical device manufacturers to provide and also explains the approach to be applied with respect to packaging. Table of Contents The Food and Drug...
FDA
The new article addresses aspects related to the processes and procedures associated with the review of Q-Sub requests. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has...
