Federal Register notice: FDA makes available a final guidance entitled Electronic Submission Template for Medical Device De Novo Requests.
Federal Register notice: FDA is making available additional draft and revised draft product-specific guidances that provide recommendations on, among ...
FDA clears a SurGenTec 510(k) for its proprietary B-MAN Bone Marrow Aspirate Kit.
Inari Medical begins a Class 1 recall to update the use instructions for its ClotTriever XL catheter after discovering serious adverse events caused w...
FDA publishes a guidance to help submitters of de novo requests use an electronic format template.
FDA clears Procept BioRobotics Hydros Robotic System used for aquablation therapy in patients with benign prostatic hyperplasia.
FDA principal deputy commissioner Namandj Bumpus says CDER correctly denied approval of a 2016 Intarcia NDA for ITCA 650 to treat Type 2 diabetes.
Federal Register notice: FDA announces a 9/26 Oncologic Drugs Advisory Committee meeting to discuss the use of immune checkpoint inhibitors in patient...
