The activities are divided into two phases
- Technical Documentation or 510k preparation
- FDA Review and Approval
Technical Documentation or 510k preparation : Depending on the device complexities, applicants team capabilities and processing of external testing labs the timeline varies between 3 months to 5 months.
FDA Review and Approval : Depending the number of pages, quality of the submitted file the review and back – and – forth file submission takeaway between 6 to 12 months.