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What counts as a Level 2 controlled correspondence: clinical review, test authorizations, and bioequivalence proposals
Summary
The forum clarified that Level 2 controlled correspondence includes items that require clinical evaluation, requests for covered product authorization to complete testing, alternative bioequivalence approaches, and instances that need inter-office consultation.
During the presentation the presenter described the scope of Level 2 controlled correspondence: “And it includes instances for submissions if for example, clinical content needs to be evaluated, if you're requesting a covered product authorization to complete testing and development, if you propose a bioequivalence approach other than what is in the published product specific guidance, And in cases where other offices need to be consulted or other sensors need to be consulted.”
She urged applicants to choose Level 2 only when those conditions apply because Level 2 reviews are expected to take longer and may trigger consultations with other FDA offices. Examples were framed to help applicants avoid misclassification that could delay review.
