December 11, 2017

Dec

FDA Clinical Decision Support SW Draft Guidance

December 11, 2017Amy SellersNews

On Dec. 8, 2017, the FDA released the draft guidance, “Clinical and Patient Decision Support Software.” This guidance addresses software for decision support in two categories: one used by Healthcare Professionals, the other used personally by patients and non-health professionals. It provides FDA interpretation of which types of Decision Support Software do not meet the...

Dec

FDA SAMD Clinical Evaluation Final Guidance

December 11, 2017Amy SellersNews

On Dec. 8, 2017, the FDA released the final guidance, “Software as a Medical Device (SAMD): Clinical Evaluation.” The October 14, 2016, draft is now obsolete. This guidance is actually the use of an International Medical Device Regulators Forum (IMDRF) document completed in June of 2017, so this represents broad international consensus. This guidance discusses...

Dec

FDA Changes to Medical SW Policies Draft Guidance

December 11, 2017Amy SellersNews

On Dec. 8, 2017, the FDA released draft guidance, “Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act.” This guidance discusses software functions in relation to the modified device definition in the 21st Century Cures Act and the criteria for interpreting if and how medical software will or...

Dec

FDA Clinical Decision Support SW Draft Guidance

December 11, 2017Alan KusinitzNews

On Dec. 8, 2017 FDA released a Draft guidance “Clinical and Patient Decision Support Software”. This guidance addresses software for decision support in two categories: one used by Healthcare Professionals, the other used personally by patients and non-health professionals. It provides FDA interpretation of which types of Decision Support Software do not meet the definition...

Dec

FDA Changes to Medical SW Policies Draft Guidance

December 11, 2017Alan KusinitzNews

On Dec. 8, 2017 FDA released a Draft guidance “Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act”. This guidance dsicusses software functions in relation to the modified device definition in the 21st Century Cures Act and the criteria for interpreting if and how medical software will or...

FDA Clinical Decision Support SW Draft Guidance

FDA SAMD Clinical Evaluation Final Guidance

FDA Changes to Medical SW Policies Draft Guidance

FDA Clinical Decision Support SW Draft Guidance

FDA Changes to Medical SW Policies Draft Guidance

SoftwareCPR Training Courses

Corporate Office

Day

FDA Clinical Decision Support SW Draft Guidance

FDA SAMD Clinical Evaluation Final Guidance

FDA Changes to Medical SW Policies Draft Guidance

FDA Clinical Decision Support SW Draft Guidance

FDA Changes to Medical SW Policies Draft Guidance

SoftwareCPR Training Courses

Corporate Office