- FDA Issues Draft Guidance on Postmarket Cybersecurity of Medical Devices (January 20, 2016)
- FDA Issues Final Guidance Eliminating Regulatory Controls on Medical Device Data Systems, Imaging Storage Devices, and Imaging Communications Devices (February 11, 2015)
- The Cure for the Common FDA Reform Legislation? House Committee Releases 21st Century Cures Discussion Draft (February 2, 2015)
- FDA Draft Guidances on General Wellness Products and Device Accessories Continue Risk-Based Approach to Health IT (January 26, 2015)
- FDA Approves Cancer Screening Test as First Device Under Parallel Review Pilot (August 21, 2014)
- FDA Releases Long-Awaited LDT Regulatory Framework and Finalizes Companion Diagnostics Guidance (August 8, 2014)
- FDA Issues Final Guidance on Evaluating Substantial Equivalence in 510(k) Submissions (August 6, 2014)
- FDA Issues Draft Guidance Eliminating Regulatory Controls on Medical Device Data Systems, Imaging Storage Devices, and Imaging Communications Devices (June 27, 2014)
- FDA Issues Final Guidance on Mobile Medical Apps: “De-Regulatory” Move Helps Clarify Certain Key Questions, But Leaves Others Open (September 25, 2013)
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