Submitting medical device applications to the U.S. FDA requires not only accurate regulatory content but also the correct submission format. The FDA now strongly encourages the use of eSTAR (Electronic Submission Template And Resource) for 510(k) and De Novo submissions, while eCopy remains the standard for PMA and certain other applications. Failure to provide properly formatted files can lead to refuse-to-accept (RTA) letters, costly delays, and extended review timelines.

At XPRO AMERICA, we specialize in preparing FDA-compliant eSTAR and eCopy submissions, ensuring that your device application is accepted at first submission without formatting-related rejections.

What is FDA eSTAR?

The eSTAR template is an interactive PDF designed by FDA to standardize submissions and streamline the review process. It prompts applicants to provide all necessary content, from device descriptions to performance testing, in a structured, reviewer-friendly layout. FDA now prefers eSTAR for most 510(k) and De Novo filings, making it the future of device submissions.

What is FDA eCopy?

For PMA, IDE, HDE, and certain legacy applications, FDA still requires eCopy submissions. This is a standardized electronic format (on CD, DVD, or USB) that must meet FDA’s technical requirements, including folder structure, file types, and size limits. Incorrect eCopy formatting is a common reason for submission delays.

Our eSTAR & eCopy Services:

• Submission Conversion: Transforming your full regulatory dossier into FDA-compliant eSTAR or eCopy format.
• Formatting & Validation: Ensuring all content meets FDA’s Technical Standards for eCopy and eSTAR PDF rules.
• Readiness Checks: Running validation tools before submission to prevent rejections.
• Document Organization: Structuring modules (device description, labeling, testing data, risk analysis) for reviewer efficiency.
• Regulatory Support: Advising on whether your device should be filed via eSTAR, eCopy, or eCTD, depending on classification and pathway.

Why Choose XPRO AMERICA?

• Experienced in FDA electronic submission formatting.
• Proven track record of first-pass acceptance without RTA delays.
• Expertise across all device submission types: 510(k), PMA, De Novo, and IDE.
• Time-saving, cost-effective compliance solutions.

By leveraging XPRO AMERICA’s expertise, manufacturers ensure their submission not only meets content requirements but is also formatted to FDA standards—eliminating unnecessary delays and expediting product approvals.

XPRO AMERICA ensures FDA-ready eSTAR and eCopy submissions, converting dossiers into fully compliant formats for faster 510(k) and PMA reviews.