Medcrypt developed this 14-question survey to help Medical Device Manufacturers determine whether or not they are prepared for an FDA Submission. 

Please check off specific boxes as applicable. Note that a checked box presumes that you can share specific and partial or complete documentation immediately. 

Responses to this checklist will inform a follow-up engagement call where our team of experts can share any insights gathered. 

Please note: This survey and the information included within it do not constitute a regulatory assessment for legal purposes and do not have legal impact on the FDA submission process.