Senior-led FDA regulatory consulting for medical device companies navigating complex classifications, submissions, and high-stakes FDA interactions.
Chosen for nearly two dozen FDA data-integrity audits.
Built for inspections, not just enrollment.
Decades guiding high‑stakes medtech and biotech programs.
Getting a medical device to market through the FDA requires more than filling out the right forms. Classification, predicate strategy, evidence requirements, and submission pathway all interact — and the decisions you make early in development shape the cost, timeline, and risk profile of everything that follows.
Health Policy Associates (HPA) provides senior-led medical device regulatory consulting for sponsors who need clarity on how the FDA will view their product and what that means for the path ahead. Whether you’re preparing a first-time 510(k), navigating a De Novo classification, building an IDE application, or recovering from a submission the FDA has challenged, we help you understand where you stand, close the gaps that matter, and move forward with a plan your team can defend.
We provide you with a concrete regulatory plan: clear documents and working sessions that move your device program from uncertainty to a path you can stand behind.
Sponsors commonly seek our support when:
The scope of a medical device regulatory engagement depends on where the sponsor is in development, what the FDA has already said, and which decisions need to be made.
Typical engagements include some or all of the following.
We assess your device’s classification, intended use, risk profile, and predicate landscape to develop a defensible regulatory strategy and submission map. This includes confirming or adjusting the likely FDA pathway and mapping the key submissions, regulatory interactions, and timing that inform your development plan and budget.
We help you determine when a Pre-Submission (Q-Sub) is the right move, develop focused questions designed to surface the FDA’s substantive position, and draft the briefing package with the supporting rationale and evidence the FDA needs to respond with specificity.
When a meeting is part of the process, we prepare your team and help interpret the FDA’s written response.
We draft and compile submission content, including device descriptions, predicate comparisons, performance testing summaries, clinical data packages, and labeling, to help ensure the agreed regulatory strategy and classification rationale are reflected throughout.
Where appropriate, we also review applicable FDA guidance and relevant regulations to support strategic decision-making.
If your internal team or another consultant has drafted the submission, we provide an in-depth review for strategy alignment, completeness, and language risk, including detailed redlines and alternative framing options where the current language may trigger unnecessary FDA questions or unintended classification issues.
We assess your testing, data, and documentation against the FDA’s expectations for your specific device classification and pathway, identifying what is missing or misaligned and providing a prioritized plan to close gaps. This may include recommending labs and vendors, timing and sequencing considerations, and budget implications.
For sponsors recovering from adverse FDA decisions such as NSE letters, deficiencies, rejected Breakthrough Device Designation requests, or challenged submissions, we help rebuild the regulatory narrative, reframe the product’s classification or predicate strategy, and prepare a repositioned submission designed to improve the outcome.
Some device programs need support beyond regulatory strategy and submission work. When the product or program demands it, we can extend the engagement to include:
We scope these extensions based on your device’s specific regulatory and clinical requirements, and can connect the work directly to our:
Clinical Trial Strategy & Execution, Quality Systems & Compliance Consulting, and Combination Product Consulting services.
When the stakes are high, HPA turns ambiguity into clear findings, prioritized risks and next steps, so your team stops debating in gray areas and starts moving with conviction.
HPA helps you make decisions and build evidence that holds up under FDA questioning—especially when data integrity, framing, or compliance concerns could derail your program.
Our senior-led team stays with you and manages scope changes transparently, so you avoid handoff drag, reduce rework, and control spend without the change-order spiral.
If your device program requires clinical evidence, we can extend the engagement into Clinical Trial Strategy & Execution, so your regulatory and clinical efforts stay aligned from strategy through execution.
When you’re facing a pivotal submission, an FDA letter that changes the plan, or a device classification that doesn’t align with your development roadmap, the biggest risk isn’t moving slowly but moving in the wrong direction.
HPA brings senior-led, audit-grade regulatory judgment to your medical device program so you can choose a defensible path, close the gaps that matter, and move forward with a plan your team, leadership, and investors can stand behind.
