TPRG’s efficient and expert review process gets your device moving through the clearance process fast. TPRG is formally recognized and accredited by FDA to perform premarket notification third-party reviews. We value our customers and the services we provide.
TPRG 심사 트랙
Review Phases Include:
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- eSTAR ACCEPTANCE: The submission will be accepted when all administrative elements are present, or a rationale provided for those elements determined by the submitter to be not applicable. Estimated timeline ± 3 days depending on the volume and accuracy of information submitted. The applicant is afforded a maximum of two ACCEPTANCE rounds. Applicants can also request a 24-hour ACCEPTANCE review for an additional small fee.
- eSTAR SUBSTANTIVE: Upon successful completion of the ACCEPTANCE phase, TPRG next performs the scientific assessment and formally documents the review. Applicants are notified of any identified deficiencies and provided with an opportunity to provide corrective actions. Estimated timeline ± 10 days depending on the volume and accuracy of information submitted. The applicant is afforded a maximum of two SUBSTANTIVE rounds.
- FDA REVIEW Phase: Once our review is forwarded to FDA we will continue to monitor your submission. By law FDA has 30 days to render a final decision.
- 신속한 검토를 통해 제출일로부터 22~35일 이내에 허가를 받을 수 있습니다.
