MDR Data Files
Posts published in “United States Department of Health & Human Services – HHS”
Expanded Access for Medical Devices
Statement on agency’s efforts to increase transparency in medical device reporting
Mouse Embryo Assay for Assisted Reproduction Technology Devices
Digital Health Update: The FDA Announces an Opportunity for Test Case Volunteers for the Test Plan for the Software Precertification Program
The FDA issued the first warning letter for UDI violations to help ensure compliance
Utilizing Animal Studies to Evaluate Organ Preservation Devices
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