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FDA Submission & Agency Support provides hands-on regulatory leadership to guide your in vitro diagnostic program through FDA interactions and premarket submissions. We support preparation, review, and submission of regulatory filings, including Pre-Submissions, 510(k)s, CLIA Waivers, De Novo requests, and Emergency Use Authorization (EUA) submissions, with a focus on clarity, completeness, and alignment with FDA expectations.
This service includes strategic support for FDA communications, meeting preparation, and response to FDA questions or deficiency requests. We help you present your data effectively, anticipate reviewer concerns, and navigate feedback efficiently—reducing delays and uncertainty during the review process.
FDA Submission & Agency Support is ideal for diagnostic developers who need experienced regulatory guidance to manage FDA interactions, compile submission-ready documentation, and move confidently toward clearance, authorization, or approval.