Clinical & IDE Practice

What This Practice Does

The Clinical & IDE Practice supports device companies through the clinical side of FDA regulation: IDE Pre-Submission strategy, full Investigational Device Exemption application preparation, U.S. Sponsor of Record responsibilities under 21 CFR 812 for sponsors based outside the United States, Early Feasibility Study (EFS) pathway planning, and Breakthrough Device Designation requests. The practice also provides monitoring oversight and site coordination with named clinical staff, IRB and site start-up documentation, and the annual and final reports an active IDE study requires for the life of the trial.

Cardiovascular Focus

Cardiovascular and cardiac rhythm devices carry distinct FDA expectations: a refined target population, clearly defined device success criteria, and comparison against available transcatheter and surgical alternatives. The Clinical & IDE Practice has supported Breakthrough Device requests and IDE planning for transcatheter structural heart devices, lead management systems, and cardiovascular software, and structures Pre-Submission questions around the points FDA has historically raised in these reviews.

Working With Non-U.S. Sponsors

A device company based outside the United States that wants to run an IDE study here needs a U.S. Sponsor of Record — an entity that takes on the full set of Part 812 sponsor obligations, including monitoring, reporting, and direct accountability to FDA. The practice also handles the related but distinct U.S. Agent and official correspondent roles that keep FDA correspondence flowing to a single, reachable U.S. contact.

One recurring, practical situation is the correspondent-of-record transition: what happens when a sponsor changes its U.S. representative mid-program. At a basic level, this is a letter from the sponsor to the lead FDA reviewer identifying the new correspondent, with the outgoing correspondent's acknowledgement, so that an existing Q-Sub or IDE file transfers cleanly without resetting FDA's institutional memory of the program. The practice manages this handoff in either direction — incoming or outgoing — so a sponsor changing CROs doesn't lose continuity with FDA.

Typical Engagement Flow

A clinical engagement usually opens with a Pre-Submission strategy session to pressure-test the proposed study design against what FDA is likely to expect, followed by IDE application drafting, IRB coordination, and site start-up documentation once the pathway is set. For non-U.S. sponsors, the U.S. Sponsor of Record relationship is established in parallel so the study can open without waiting on a separate, sequential engagement. Once the study is active, the same practice director handles monitoring oversight, annual and final report preparation, and any protocol amendments the study needs along the way.

Why a Single Director of Record Matters

An active IDE study runs for years, not months — annual reports, adverse event reporting, protocol amendments, and site-level questions all flow back through the sponsor relationship for the life of the study. A clinical program that changes its FDA-facing lead partway through risks losing the institutional memory of why a protocol decision was made a year earlier, or what FDA's reviewers flagged as a concern at the original IDE approval. This practice is built so the director who designed the IDE strategy is the same person still answering FDA's questions when the study reaches its final report.

Who Leads It

Practice Director, Clinical & IDE. Your practice director is named in the proposal and statement of work.