21 CFR 803 Definition for 'Substantial Harm"

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Part 803 indicates the reporting requirements if a device has or could cause 'serious injury' for which it also provides a clear definition for. It further explains reporting requirements when "remedial action to prevent an unreasonable risk of substantial harm to the public health" is required. However it does not provide a definition for 'substantial harm' and I can't find information anywhere elaborating on what 'substantial harm' infers.

Does anyone know if 'substantial harm' is the same as 'serious injury' or if it has a different definition?

Thanks.
Dave

 

[John Broomfield]

Part 803 indicates the reporting requirements if a device has or could cause 'serious injury' for which it also provides a clear definition for. It further explains reporting requirements when "remedial action to prevent an unreasonable risk of substantial harm to the public health" is required. However it does not provide a definition for 'substantial harm' and I can't find information anywhere elaborating on what 'substantial harm' infers.

Does anyone know if 'substantial harm' is the same as 'serious injury' or if it has a different definition?

Thanks.
Dave

Dave,

Serious injury does not include death or mortal injury whereas substantial harm could include a wide range of substantial harms from widespread loss of workdays all the way up to and including death or deaths in terms of public health.

So, the exact potential for substantial harm depends on the characteristics of your product throughout its lifecycle.

This explains why a generic definition may not work as well as the results of your own risk assessments that are specific to the potential hazards posed by your product throughout its lifecycle.

Of course, the regulator itself cannot anticipate these.

John