What is the risk analysis requirements from the QSR and ISO regulations for medical devices that were manufactured prior to 1998? From my understanding devices manufactured prior to 1998 are exempt from design control. If we are still marketing these products do we have to create a risk analysis as part of postmarket surveillance?

Thanks in advance,

Billy

Billy,

Product designed prior to the introduction of the QSRs are not design exempt except under a very limited scope (the design must have been established prior to the introduction of the requirements and cannot have changed ). FDA will expect that with the first change that an organization evaluate the design at that point and establish all relevant design/technical documentation. Risk Analysis documentation is included in those considerations. If design/tech/risk docs weren't established back then, you'll in all likelihood need to create them now.

From a postmarket surveillance perspective, you may elect to create a risk based approach whereby matured product undergoes a lighter risk management activity and subsequently have ligher risk management documentation. Depending on how you have established the risk management plan, the requirements for your design would likely vary. For a 10 year old design that only undergoes light sustaining activities, the plan would likely be less aggressive than a risk plan for a new design of a similar nature. Try not to create a one-size-fits-all solution as this will likely create unnecessary burden on your resources and time.

Regards,

Kevin