Sam Lazzara
Trusted Information Resource
What is the relevance of "Time Zero" testing for medical devices from the standpoint of meeting regulatory requirements to defend your labeled shelf life?
In my research, I have found no requirements or mention of this issue in any medical device regulations or standards or FDA guidance. In the past several years, I have seen letters written to my clients where FDA is recommending Time Zero testing in addition to accelerated and real-time aging.
My argument is that while Time Zero test results may be intellectually interesting, in comparison to the aging timepoints, to show changes/trends, they do not support the labeled shelf life (Use By date) and are therefore not necessary. And I have (almost) never come across a situation where polymeric device performance improves due to aging.
What is the legal, regulatory basis for performing Time Zero testing?
In my research, I have found no requirements or mention of this issue in any medical device regulations or standards or FDA guidance. In the past several years, I have seen letters written to my clients where FDA is recommending Time Zero testing in addition to accelerated and real-time aging.
My argument is that while Time Zero test results may be intellectually interesting, in comparison to the aging timepoints, to show changes/trends, they do not support the labeled shelf life (Use By date) and are therefore not necessary. And I have (almost) never come across a situation where polymeric device performance improves due to aging.
What is the legal, regulatory basis for performing Time Zero testing?