Submission File Service
FDA Submission File Service
The FDA submission process can be complex, time-consuming, and detail-heavy. Whether your medical device follows the 510(k) route or requires a more extensive Premarket Approval (PMA), submitting a fully compliant file is essential for gaining market access in the United States.
You can have a full-service solution for compiling your FDA submission documents—from strategic planning to eCopy formatting.
At Sobel, we offer support to check if your file is accurate, complete, and aligned with all FDA submission requirements, so you can submit with clarity and confidence.
How We Support Your FDA Submission
An FDA submission file is the formal set of documents required for regulatory clearance or approval of a medical device in the U.S. market.
Depending on your product, this includes 510(k) submissions for equivalence-based clearance or PMA submissions for higher-risk devices that require more robust evidence. Here’s what we do for you:
510(k) Submission File Support
Evaluate device classification, intended use, and identify the appropriate predicate device
Compile required documentation: device description, technical specs, preclinical/clinical data, labeling, and more
Provide expert review and guidance to align with FDA regulations and expectations
Format and prepare your eCopy for submission, checking the technical compliance
PMA Submission File Support
Develop a tailored pre-submission strategy, including required studies and clinical trial planning
Compile comprehensive documentation covering technical, preclinical, and clinical data
Assist with regulatory correspondence, including responses to FDA requests for additional information
Prepare and organize eCopy submissions, using modular PMA strategies when applicable to streamline review
Why do you need this service?
We help you build a fully compliant submission, minimizing the risk of rejection or requests for additional data—saving time and resources.
Not sure whether you need a 510(k) or PMA? We assess your device and guide you through the appropriate regulatory route from the start.
Submission is only the beginning. We assist with post-market reporting and documentation updates to keep your device in line with evolving FDA requirements.
FDA submissions involve strict formatting, technical depth, and regulatory expectations. That’s why, with the right partner, you gain technical precision and strategic insight every step of the way.
A well-prepared FDA submission file doesn’t just support approval—it builds credibility with regulators and helps you avoid costly delays.
Looking for 510(k) or PMA Assistance?
Whether you’re preparing a 510(k) or PMA, Sobel offers comprehensive Submission File Services to help you meet FDA requirements with clarity and confidence.
Let us streamline the process—so you can focus on getting your device to market. It is a complete 510(k) & PMA File preparation for confident U.S. Market Entry.
