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FDA explains covered product authorizations, sample handling and device evaluation rules
Summary
The presenter advised that covered product authorization requests must state whether samples are for human use and include study protocols and informed consent for human studies; device evaluations require innovator and proposed device samples and only one prototype is reviewed at a time.
The presenter told attendees what to include when requesting a covered product authorization: “When requesting a covered product authorization for testing and development, please clearly state if the samples will be used in humans or they will not be used for human use. The submissions for covered product authorization in humans should also include study protocols and informed consent documents.”
For device evaluations the presenter said applicants must send samples of the innovator and the proposed device and that only one prototype is reviewed at a time. To reduce delivery problems, she recommended sending samples without a required signature and not under temperature control and to reference delivery confirmation in the control correspondence.
