Essential Design Outputs for SAMD

[leadfoot]

I am new to the company, new to SAMD, but not new to medical device regulations. The company has documented a medical device software with no EDO. I don't think the definition of EDO is aligned with FDA regulations. Here is how they define:

Critical Component:​

A component, or sub-assembly, whose failure to perform as per specification could reasonably be expected to lead to unacceptable safety risk and/or the need for corrective field action.​

Critical components are considered to be the essential design outputs for the proper functioning of the device.​

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In the design control procedure, there is no use of the terms "Essential Design Outputs", "Design Output", "Critical Components." The Risk Management file states that the risks associated with the software are not safety risks, hence there are no Critical Components (and, by definition then, no Essential Design Outputs.)

I feel we are missing on two points: 1) Identifying Essential Design Outputs is not limited to those that can impact safety risk, but any that can impact the proper functioning. A mechanical pencil can have essential design outputs. 2) Identifying EDOs is not "where applicable."

I have found the few pieces of information the FDA has published related to design controls and design outputs. It's not super definitive. Is there any additional published information that I can use to improve our understanding of EDO? Thanks!

 

[Tidge]

This is not "the truth", but this is how I think about "critical components" in the context of safety. IMO In the world of Medical Devices this should be the only context for the term "critical components".

• Finished goods are not critical components; (medical device) finished goods are required to be safe and effective.
• There are no "critical components"; there are only "critical characteristics" of components.
• A characteristic of a component critical in one design may not be critical in another design.
• A characteristic is critical (in a given design) if the existence and specification of that characteristic is specifically identified as the control that makes an otherwise unacceptable risk acceptable.

There of course can be all sorts of characteristics identified as "critical"; but the question will always be "critical to what?" The answer could be something like 'process stability' or 'cost'.

 

[Tidge]

I feel we are missing on two points: 1) Identifying Essential Design Outputs is not limited to those that can impact safety risk, but any that can impact the proper functioning. A mechanical pencil can have essential design outputs. 2) Identifying EDOs is not "where applicable."

Here is a bit of anecdotal history from a greybeard: It used to be possible to get "60601 certification" for devices like ventilators that would stop working if they tipped over, as long as the ventilators didn't catch fire or shock people when they tipped over. It was recognized that this was not really a meaningful sort of certification, so nowadays we talk about not just basic safety but also essential performance.