What is meant by "post production" if the device is yet to receive FDA approval?

[bassel]

Hi All
I am new to the Risk Management field. I was puzzled by the repeated mention of the ISO 14971 (and 24971) of the so called "post production" data. The reason of my bewilderment is that a new entrant to the market seeking FDA certification does not yet have a production line. So how can such a new entrant provide or make use of "post production" data?

 

[Tidge]

Risk Management is applicable over the entire life-cycle of a device. The risk management plan (RMP) for a device (or family of devices) should be requiring periodic risk reviews of the device. These periodic reviews typically consider design changes, production data, and customer complaints.

 

[EmiliaBedelia]

Seconding Tidge above - risk management is a cyclical process that should link up to clinical reviews and post market surveillance.

It is also good practice to review data from similar products on the market as a benchmark. FDA uses the Total Product Life Cycle database to link up premarket authorizations and postmarket surveillance/MDRs/AEs with product codes, and EUDAMED/other registries are intended to provide similar information OUS. If you don't have any data yourself it can be helpful to review common issues with other devices and ensure that they are considered.

 

[Tidge]

Excellent advice from @EmiliaBedelia w.r.t. reviewing similar devices already on the market.

 

[d_addams]

to add to the wise advice above, your RM policy and RM plan should cover these aspects even during development so that you aren't faced with with an urgent update to your RM policy or plan once your design becomes production released.
Emilia's advice is sound, but I'd note such information should already be available as a design input when you initiated product development (and risk management). Your RM Plan would ensure you're continuing to monitor that information throughout the development process.

 

[bassel]

to add to the wise advice above, your RM policy and RM plan should cover these aspects even during development so that you aren't faced with with an urgent update to your RM policy or plan once your design becomes production released.
Emilia's advice is sound, but I'd note such information should already be available as a design input when you initiated product development (and risk management). Your RM Plan would ensure you're continuing to monitor that information throughout the development process.

Thank you all. It appears to me that post production risk analysis may be included in the risk management plan only rather than the risk management report because it is all a matter of speculation based on others' experiences.

 

[d_addams]

Thank you all. It appears to me that post production risk analysis may be included in the risk management plan only rather than the risk management report because it is all a matter of speculation based on others' experiences.

to add to this. Do not confuse the use of the word production in the FDA documents with post-market clearance experience. Once you have applied design controls and the manufacturing process is qualified, any malfunctions of units coming off that production line and/or things like yield monitoring, etc. are subject to post-production processes.

Say you're ready to commercialize but only need FDA approval. The FDA has a follow-up question, and you build a batch of product from your production line (that is qualified/validated) to test to generate the data the FDA has requested. You determine several units fail to meet their requirements; this is post-production data even if you haven't sold any units. So something like a CAPA may need to be created based on this post-production data. This also would apply to units intended for clinical evaluation (again prior to commercialization).