All-in-one Software Solution and Expert Consulting for Medical Device and Drug Combination Product Design Controls, Risk Management, Cybersecurity, and Safety Assurance Cases
The FDA requires that a safety assurance case be included in 510(k) submissions for infusion pumps. Most of the combination products are drug delivery devices like infusion pumps, and would be expected to have information like safety assurance cases be included in the submissions.
What is Assurance Case?
Assurance case (for medical device) is basically a communication method to demonstrate assurance of safety, effectiveness and performance. It organizes information into explainable structure, and demands evidences and critical thinking ("asking whys") for both the authors & reviewers. It is an excellent tool to advance regulatory science through improving effectiveness and productivity of regulatory submission process. Safety assurance cases are to demonstrate assurance of safety. Constructing safety assurance cases involves critical thinking on the completeness and correctness of adequacy of V&V, risk mitigation, and reliability. When being proactively developed, safety assurance case becomes an excellent safety engineering technique to identify /address weakness in design controls, risk management practices.
When are Assurance Cases needed?
Currently all infusion pump submissions are required by FDA to include safety assurance cases, and most of drug delivery combination product submissions are implied to provide device safety assurance case information. There have been shared examples that manufacturers are using assurance case method on combination products. There have been practices that assurance case method is used to assure and demonstrate cybersecurity. There has been ongoing research to use assurance case method to address other FDA hot topics, such as AI system safety.
Where to get Assurance Case Training?
Number of assurance case classes, workshops and webinars have been organized by AAMI or PDA with instructors from FDA, GessNet consulting and industry. Contact AAMI, PDA, or GessNet for future offerings.
Could Assurance Case Requirement is expanded in the future?
In the IOM (Institute Of Medicine) 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, 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.
A Glance at Safety Assurance Case History for Medical Devices
In July 2019, the FDA recognized AAMI TIR38:2019 Medical device safety assurance case guidance, which currently represents FDA's latest thinking on safety assurance cases.
In August of 2016, AAMI offered a webinar "Annual Updates with FDA: Assurance Cases for Medical Devices", where FDA provided latest update reflecting their latest thinking on safety assurance cases at the time.
In Feb 2015, AAMI offered a webinar "FDA Final Guidance on Infusion Pump TPLC & Safety Assurance Cases", where FDA representatives joining as panelists.
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 benefited 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
In April of 2010, FDA issued: Guidance for Industry and FDA Staff - Total Product Life Cycle: Infusion Pump - Premarket Notification [510(k)] Submissions