Utilizing Animal Studies to Evaluate Organ Preservation Devices
Posts published in “USA”
Laser Products – Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 (Laser Notice No. 56) Classification and Requirements for Laser Illuminated Projectors…
Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program
Priority List of Patient Preference-Sensitive Areas
Reorganization of The Center for Devices and Radiological Health Office of Product Evaluation and Quality Implementing a Team-Based Approach to Medical Device and Radiological Product…
Patient Preference Information (PPI) in Medical Device Decision-Making
Statement from Jeffrey Shuren, M.D., J.D., Director of the FDA’s Center for Devices and Radiological Health, on new steps to help reduce risks associated with…
dCharacterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devicehttps://www.fda.gov/media/95791/downloads
Unique Device Identification: Convenience Kits
Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions