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.

XPRO AMERICA provides eSTAR and eCopy submission support for 510(k), De Novo, and PMA FDA electronic device filings.

The 510(k) Premarket Notification is the primary FDA submission pathway for most Class II medical devices. It demonstrates that a new device is substantially equivalent to a legally marketed predicate device. Proper preparation, documentation, and FDA interaction are critical for timely clearance and market access in the United States.

At XPRO AMERICA, we provide comprehensive support for manufacturers and importers to prepare, submit, and manage 510(k) premarket notifications, ensuring compliance with FDA regulations and accelerating device approval.

Key Services:

• Substantial Equivalence Evaluation: We compare your device to legally marketed predicate devices to determine substantial equivalence, ensuring the correct classification and submission pathway.
• 510(k) Submission Preparation: Our team prepares the 510(k) dossier, including device description, intended use, labeling, performance data, biocompatibility testing, and risk assessments in accordance with FDA guidance.
• FDA Interaction & Communication: XPRO AMERICA manages communications with FDA reviewers, responds to requests for additional information, and facilitates clarifications to support smooth and timely review.
• Technical & Documentation Support: We review design files, testing reports, labeling, and software documentation to ensure completeness, compliance, and readiness for FDA review.
• Post-Clearance Guidance: Once the FDA issues clearance, we assist with device listing, establishment registration updates, and post-market regulatory obligations to maintain ongoing compliance.

Why Choose XPRO AMERICA?

• Extensive experience preparing and submitting 510(k) notifications for Class II devices.
• Strategic guidance to reduce review cycles and regulatory risk.
• End-to-end support from dossier preparation to FDA clearance.
• Proven expertise in regulatory documentation, testing compliance, and reviewer liaison.

Partnering with XPRO AMERICA ensures that manufacturers and importers of Class II devices achieve timely 510(k) FDA clearance, maintain regulatory compliance, and streamline their pathway to market. Our services provide confidence, minimize risk, and ensure smooth FDA interactions throughout the premarket notification process.

XPRO AMERICA supports 510(k) submissions for Class II devices, demonstrating substantial equivalence and managing FDA interactions until clearance.