FDA Uses Feedback to Finalise 2021 GuidanceMedical Devices
The FDA’s 2021 draft was coined “a useful resource for the requirements and expectations for clinical post approval studies” by Roche's Foundation Medicine.
Although it had generally optimistic feedback, there were still some people who asked for alterations to be made, with “some of the reporting requirements and timelines suggested” being “burdensome.”
“Instead of the recommended 30 days, the diagnostic developer requested that they give three times that length of time to create clinical procedures“
To address the feedback given, the organisation revised the wording, but kept some of the timelines that Foundation Medicine were unsure about.
Instead of the recommended 30 days, the diagnostic developer requested that they give three times that length of time to create clinical procedures because it “can be highly resource intensive, involving the participation of medical, statistical, and development subject matter expertise.”
The FDA has also added details on when it would allow modifications to the protocol in regard to research milestones.
While “delays sometimes may occur,” they do not “intend for sponsors to routinely modify” protocol milestones.
They wish for sponsors “to act with due diligence to mitigate continued study delays.” But they will definitely take into account sponsors’ actions towards mitigation while assessing growth reports.
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