MAPP 6020 Rev. 2, the Food and Drug Administration policy manual governing resubmissions following a CRL, classifies CRLs as requiring a Class 1 or Class 2 resubmission. Where a sponsor decides to submit a response to a CRL, the response is classified within 30 days, if the response is complete. A Class 1 response typically denotes minor amendments, such as labelling, assay validation data or minor re-analysis of the data supporting the application, while a Class 2 response typically involves more extensive concerns and/or a reinspection. A Class 1 response is typically handled within 3 months, while a Class 2 response is typically handled within 6 months.
