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. The assessment of the pilot study has begun in August, 2011. Here is the journey of safety assurance case for medical devices.
1. In April of 2010, FDA issued: Guidance for Industry and FDA Staff - Total Product Life Cycle: Infusion Pump - Premarket Notification [510(k)] Submissions
2. In May of 2010, FDA called a Public Meeting: Infusion Pump Workshop
3. 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.
4. 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.
5. 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.
6. Since end of 2011, AAMI has started offering courses on Assurance case. GessNet™ software has been used to develop assurance case example integrating with risk management.
7. In June of 2013, the FDA issued draft guidance on the content of premarket submissions for management of cybersecurity in medical devices.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, there have been number of institutions/researchers that have started the work to use assurance case for cybersecurity.