The FDA issued the first warning letter for UDI violations to help ensure compliance
Posts published in May 2019
Patient-Reported Outcomes (PROs) in Medical Device Decision Making
Ethicon Recalls Circular Staplers for Insufficient Firing and Failure to Completely Form Staples
FDA provides updates on the agency’s continued commitment to evaluating postmarket safety of Essure device
Utilizing Animal Studies to Evaluate Organ Preservation Devices
Medical X-Ray Imaging Devices Conformance with IEC Standards Policy Clarification for Certain Fluoroscopic Equipment Requirements
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
Fourth WHO Global Forum on Medical Devices REPORT
Standardization of medical devices nomenclature – International classification, coding and nomenclature of medical devices – Report by the Director-General