Collaborative Communities: Addressing Healthcare Challenges Together Webinar: Collaborative Communities – October 29, 2019 FDA in Brief: FDA announces participation in first two ‘Collaborative Communities’ working…
Posts published in “Draft Guidance”
Safer Technologies Program for Medical Devices
IMDRF draft document – Requirements for Regulatory Authority Recognition of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews
Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment
Live Case Presentations During Investigational Device Exemption (IDE) Clinical Trials
Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products — Content and Format Guidance for…
Clinical Investigations for Prostate Tissue Ablation Devices
Mouse Embryo Assay for Assisted Reproduction Technology Devices