Functional Practice
510(k), De Novo, PMA, 513(g), and Pre-Submission strategy and preparation — from predicate analysis through FDA clearance, led by a named practice director.
The Regulatory Submissions Practice prepares and manages the full range of FDA premarket filings: 510(k) submissions, including eSTAR-format packages, De Novo classification requests for devices with no predicate, Premarket Approval (PMA) applications and PMA supplements for Class III devices, 513(g) Requests for Information when a classification question needs FDA's own written answer, and Pre-Submission (Q-Sub) meetings that get FDA's feedback on strategy before a formal filing goes in. The practice also owns Refuse to Accept (RTA) responses and Additional Information requests — the back-and-forth that happens after a submission is filed — and predicate and substantial equivalence strategy, which is the single highest-leverage decision in most 510(k) programs.
Every engagement starts with intake and a gap assessment against the applicable FDA guidance and recognized consensus standards for the device type. Section owners then draft the submission content in parallel, with the practice director reviewing against FDA's own RTA checklist before anything goes out the door — the goal is to catch what an FDA reviewer would catch, before FDA does. The practice director signs off on the final package, the submission goes in through the CDRH Customer Collaboration Portal (CDRH Portal), and all FDA correspondence after filing — acknowledgment letters, interactive review questions, deficiency letters — is handled by the director of record, not handed off to whoever is available that week.
Regulatory Submissions works across every device-area group. For cardiovascular and cardiac rhythm devices, the practice leads PMA and Breakthrough Device strategy alongside the Clinical & IDE practice. For surgical, orthopedic, and ENT instruments, the practice typically runs a 510(k) or Special 510(k) pathway built around predicate and reprocessing validation strategy. For digital health and SaMD, the practice coordinates closely with the Digital Health & Cybersecurity practice on software documentation level and classification.
Most engagements begin with a kickoff call to confirm device classification and identify candidate predicates, followed by a written gap assessment scoped to the specific pathway. From there, the practice director sets a submission timeline, assigns section drafting to the right staff member for each content area, and schedules internal review milestones so the client sees a complete draft well before the filing date — not a rushed assembly in the final week. After filing, the same director tracks FDA's acknowledgment and review clock and prepares the client for what typically comes next, whether that's a straightforward clearance, an Additional Information request, or an interactive review call.
FDA submissions are a correspondence-heavy process — acknowledgment letters, interactive review emails, deficiency letters, and sometimes a Pre-Submission meeting request all arrive at different points over months. When the person who drafted the original submission is also the one reading and responding to every piece of that correspondence, nothing gets lost in a handoff and nothing gets answered by someone reconstructing context from a shared inbox. That continuity is the entire reason this practice is structured around a named director rather than a rotating submission team: the director who signed off on the predicate strategy is still there when FDA's first deficiency letter arrives six months later.
Practice Director, Regulatory Submissions. Your practice director is named in the proposal and statement of work.
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