Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices
Posts tagged as “USFDA”
FDA Qualifies MRI Compatibility and Safety Software as a New Medical Device Development Tool
Magnetic Resonance (MR) Coil – Performance Criteria for Safety and Performance Based Pathway
Modifications to the List of Recognized Standards, Recognition List Number: 052
Breast Implants – Certain Labeling Recommendations to Improve Patient Communication
Color Hazard and RISk calculator (CHRIS) is being developed and validated under the MDDT framework.
CDRH Proposed Guidances for Fiscal Year 2020 (FY 2020)
URGENT/11 Cybersecurity Vulnerabilities in a Widely-Used Third-Party Software Component May Introduce Risks During Use of Certain Medical Devices
Biological Responses to Metal Implants
Clinical Decision Support Software