M
MIREGMGR
Those of you who manufacture devices for worldwide markets, and have a QMS that is intended to simultaneously comply with FDA and EC / MDD requirements:
My conclusion from reviewing various FDA 483s, PMN review comments and other actions is that the FDA regards the failure of a device to technically perform as expected as a "harm" outcome, even if it does not result in specifically identifiable "physical injury or damage to the health of people, or damage to property or the use environment."
(That is, a failure by inaction, rather than a failure by wrong action.)
Do you use an extended definition of "harm" in your ISO 14971:2007 implementation, to take this broader expectation of device risk into account?
And a second question: do you use modified wording in your Scope statement to take into account the inclusion of animals within some devices' permissible uses within FDA jurisdiction, but the exclusion of animals elsewhere?
My conclusion from reviewing various FDA 483s, PMN review comments and other actions is that the FDA regards the failure of a device to technically perform as expected as a "harm" outcome, even if it does not result in specifically identifiable "physical injury or damage to the health of people, or damage to property or the use environment."
(That is, a failure by inaction, rather than a failure by wrong action.)
Do you use an extended definition of "harm" in your ISO 14971:2007 implementation, to take this broader expectation of device risk into account?
And a second question: do you use modified wording in your Scope statement to take into account the inclusion of animals within some devices' permissible uses within FDA jurisdiction, but the exclusion of animals elsewhere?