The FDA required that a safety assurance case be included in 510(k) submissions for infusion pumps in their draft infusion pump guidance issued in 2010. In their recommendations to modify the 510(k) program later that year, they recommended that this be expanded to 510(k) submissions for all devices. In the IOM report on the 510(k) process, released in July of 2011, the IOM recommended that a safety assurance case be used for all software in medical devices. After gathering comments on their 510(k) proposals, the FDA stated that they would use the infusion pump safety assurance case as a pilot study and assess its results before expanding the safety assurance case requirements. Here is an overview of safety assurance case journey for medical devices.
On December 2, 2014, FDA issued the final guidance requesting safety assurance cases for infusion pump submissions: Guidance for Industry and FDA Staff - Total Product Life Cycle: Infusion Pump - Premarket Notification [510(k)] Submissions
In March 2014, during the forum discussion of S3 Challenge 2014 (Organized by AAMI and the FDA), number of leaders from industry recommended to add safety assurance case method into ISO 14971 standard.
In Feb 2014, AAMI BI&T journal publishs a paper "Reducing Risks and Recalls: Safety Assurance Cases for Medical Devices" authored by Sherman Eagles and Fubin Wu. The paper has detail discussions on how safety assurance cases can address shortcomings of existing risk management practices and reduce product recalls.
In June of 2013, the FDA issued draft guidance on the content of premarket submissions for management of cybersecurity in medical devices. Although Assurance Case method is not particularly mentioned, number of institutions/researchers have been using assurance cases to address cybersecurity for medical devices.
In 2013, FDA officials have indicated the safety assurance case pilot program on infusion pump was a success: both the ageny and manufacturers have benefitied from safety assurance cases.
Since end of 2011, AAMI has started offering courses on Safety Assurance Case. GessNet™ software has been used to develop class examples in integrating with risk management.
In August of 2011, the first release of GessNet™ TurboAC™ software was installed in FDA lab. Since then, we have made number of releases in addressing various comments and feedback.
The AdvaMed infusion pump working group has been working on an example safety assurance case with the goal of creating a template. They are using the Generic Infusion Pump PCA project as the basis for the example and hope to have the FDA review and provide feedback on their approach.
AAMI has been working on a technical information report for guidance on safety assurance case reports. This activity is being done by a working group of the AAMI infusion pump committee. The goal of this group was to have a draft ready by early 2012 and a published Technical Information Report in early 2013.
In May of 2010, FDA called a Public Meeting: Infusion Pump Workshop