January 4, 2017

Jan

FDA Device Recall Summary Page

January 4, 2017Alan KusinitzNews

The FDA webpage with a summary of how medical device recalls are handled and how FDA may notify the public is at the link provided. This includes examples of types of recall actions. We post software-related recalls on this website and SoftwareCPR can provide expert assistance in compliance with 21 CFR Part 806 Corrections and...

Jan

21st Century Cures Act – Standalone SW Summary

January 4, 2017Alan KusinitzNews

The law firm of Hyman Phelps and McNamara posted their summary of the impact on this Dec 13, 2016 US Law the 21st Century Cures Act. at the link provided. Section 3060 addresses standalone software and exempts some software from regulation as a medical device. They also provide links to summaries of other provisions of...

Jan

21st Century Cures Act – Medical Device Summary

January 4, 2017Alan KusinitzNews

Hyman, Phelps & McNamara posted a great summary of the impact of the 21st Century Cures Act in regards to general provisions affecting medical device regulation. They also provide links to summaries of other provisions of the act for standalone software (also posted on softwarecpr.com), and drugs and biologics impact.

FDA Device Recall Summary Page

21st Century Cures Act – Standalone SW Summary

21st Century Cures Act – Medical Device Summary

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FDA Device Recall Summary Page

21st Century Cures Act – Standalone SW Summary

21st Century Cures Act – Medical Device Summary

SoftwareCPR Training Courses:

Subscription Services

Corporate Office