Creating and maintaining a Safety Assurance Case is an FDA requirement for certain infusion pumps (by Product Code). I believe this is the only product type for which FDA requires a Safety Assurance Case.This arose because there had been some problems with infusion pumps and some people believed that the risk management system at the time (ISO 14971:2007) was not robust enough to help prevent the observed problems. There was a time when FDA considered extending the Safety Assurance Case to all devices or, perhaps, to only other high risk devices. I don't believe there are any current plans in this area.My recommendation is to use ISO 14971:2019 and do not create a Safety Assurance Case unless the pre-market submission requires it. ISO 14971:2019 is robust enough to help identify the identify risks, identify risk reductions, and implement them in the design. However, this implies following the standard, which doesn't always happen. I don't believe a Safety Assurance Case will provide a safer device than a correctly conducted ISO 14971:2019 approach.While Ed Bills can speak for himself, when he raises traceability, I believe he refers to ISO 14971:2019, 4.5 Risk management file which says, "For the particular medical device being considered, the manufacturer shall establish and maintain a risk management file. In addition to the requirements of other clauses of this document, the risk management file shall provide traceability for each identified hazard to:- the risk analysis;- the risk evaluation;- the implementation and verification of the risk control measures; and- the results of the evaluation of the residual risks".This is not a requirement for a Safety Assurance Case, but rather a requirement for records to follow each identified hazard through the major elements of the standard.
Both Dan and Richard are correct, Safety Assurance Case is expected for infusion pumps as described in the Infusion Pumps Total Product Lifecycle guidance (issued Dec 2, 2014); additionally, AAMI TIR 38 is a consensus recognized standard by CDRH and applies to the device product codes listed on its recognition page. I'll also note that a Safety Assurance Case is generally expected for combination products that are pre-filled infusion systems, such as on-body delivery systems.
Again, solid points have been made regarding more typical risk management approaches (i.e. those described in ISO 24971 guidance accompanying 14971 vs. Safety Assurance Case (SAC), although I'll note that SAC is theoretically more of a different way of presenting the data than a different approach to risk management altogether. There are also specialized firms with dedicated software one can utilize for developing and maintaining SACs since it is a more difficult approach to document than with off-the-shelf type tools (i.e. spreadsheets), particularly for complex systems/devices.
Regulatory Affairs Professionals Society (RAPS)5635 Fishers Lane, Suite 400Rockville, Maryland 20852
email@example.com+1 301 770 2920
JoinMy RAPS DashboardLearn More