eSTAR & eCopy Submissions for FDA Devices – XPRO AMERICA
The FDA requires electronic submissions for medical device applications, including 510(k), De Novo, and PMA pathways. Two primary formats are used: eCopy and eSTAR (Electronic Submission Template And Resource). Correct formatting and submission are critical to avoid review delays and ensure regulatory compliance.
At XPRO AMERICA, we provide full-service support for preparing and submitting FDA-compliant eSTAR and eCopy submissions, ensuring accuracy, completeness, and timely submission to the FDA.
Key Services:
- eCopy Submission Support: We convert submission dossiers into FDA-compliant eCopy format, meeting all content, labeling, and technical file requirements for 510(k), De Novo, and PMA submissions.
- eSTAR Submission Support: XPRO AMERICA prepares submissions using the FDA’s eSTAR template, which standardizes electronic submissions and facilitates efficient FDA review.
- Regulatory Review & Gap Analysis: Our team reviews your submission for completeness, including device description, performance data, labeling, risk analysis, and clinical evidence, to ensure FDA readiness.
- FDA Communication & Response Management: We manage communications with FDA reviewers, address requests for additional information, and facilitate clarifications to avoid delays during the review process.
- Post-Submission Support: After submission, XPRO AMERICA tracks submission status, manages acknowledgments, and provides guidance on next steps, including labeling updates, device listing, and post-market requirements.
Why Choose XPRO AMERICA?
- Expertise in FDA electronic submission formats: eCopy and eSTAR.
- Ensures timely and accurate submission, minimizing regulatory risk.
- End-to-end support from submission preparation to FDA communication.
- Proven experience in 510(k), De Novo, and PMA submissions across multiple device types.
Partnering with XPRO AMERICA ensures that your medical device submissions are fully FDA-compliant, accurately formatted, and efficiently managed. Our services streamline electronic filing, reduce review delays, and provide confidence throughout the premarket approval process.
