Senior-led regulatory, clinical, and quality consulting for drug-device and biologic-device combination products navigating complex FDA pathways.
Chosen for nearly two dozen FDA data-integrity audits.
Built for inspections, not just enrollment.
Decades guiding high‑stakes medtech and biotech programs.
Combination products sit at the boundary between two regulatory frameworks, drug and device, or biologic and device, and the FDA does not let sponsors pick the simpler path by default.
Classification, primary mode of action, lead-center determination, quality system requirements, and submission pathway all interact, and getting any one of them wrong can reshape the entire program’s cost, timeline, and risk profile.
Health Policy Associates (HPA) provides senior-led combination product consulting for sponsors who need clarity on how the FDA will view their product and what that means for the regulatory, clinical, and quality strategy.
We help you resolve classification and pathway questions early, build a defensible submission, and align your quality system with the requirements for your specific combination product type before the FDA raises questions you haven’t prepared for.
We help you work through these questions in the right sequence, so each decision builds on the last and your team walks away with a defensible, unified plan
Sponsors commonly seek our support when:
The scope of a combination product engagement depends on where the sponsor is in development, what the FDA has already said, and which questions need to be resolved.
Typical engagements include some or all of the following.
We assess your product’s constituent parts, intended use, and mechanism to develop a defensible classification rationale and primary mode of action position, helping you avoid an unfavorable Request for Designation (RFD) outcome or challenge an existing one
We map the full submission pathway, including lead center, applicable premarket submission type, Pre-Sub strategy, and key regulatory interactions, with sequencing and timing that inform your development roadmap and budget.
We review draft submissions for strategy alignment, completeness, and language risk, with attention to the cross-functional framing that combination product submissions require and the specific areas where imprecise wording triggers unintended classification or review questions.
We assess your testing, data, and documentation against the FDA’s expectations for your specific combination product type and pathway, identifying what is missing or misaligned and providing a prioritized plan to close gaps.
We evaluate your current quality system against 21 CFR Part 4 CGMP requirements, identify which streamlined compliance approach fits your product, and map the specific provisions you need to demonstrate before inspection.
For sponsors recovering from adverse classification decisions, unfavorable RFD outcomes, or challenged submissions, we help rebuild the regulatory narrative, reframe the primary mode of action, and prepare a repositioned submission designed to change the FDA’s view.
Combination products often require clinical evidence that satisfies the expectations of more than one FDA center. HPA supports sponsors across two areas that directly affect submission quality and inspection readiness.
01
We design and manage clinical studies for combination products with attention to the specific endpoints, safety reporting, and monitoring requirements shaped by the product’s classification and lead center.
Our trial operations are built for audit-grade rigor, with inspection-ready documentation and data quality controls in place from startup through closeout.
02
We build and manage clinical databases with real-time data access, programmed edit checks, and query resolution workflows designed to surface data quality issues early.
For combination products, where data integrity scrutiny is heightened, our approach reflects the standards shaped by HPA’s experience in nearly two dozen FDA data-integrity audits.
Some combination product programs need support beyond regulatory strategy and clinical operations.
When the product or program demands it, we can extend the engagement to include EU-to-US gap assessments for sponsors transitioning CE Mark technical files to U.S. IDE or other pathways, human factors engineering support, and preparation for FDA advisory committee meetings.
We scope these extensions based on your product’s specific regulatory and clinical requirements.
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 combination product program requires broader support, we can extend the engagement into Regulatory Consulting Services or Clinical Trial Strategy & Execution, so your regulatory, clinical, and quality efforts stay aligned from strategy through execution.
Combination products carry more classification risk, more quality system complexity, and more cross-functional dependency than most single-pathway programs.
The sponsors who navigate them well are usually the ones who resolve the hardest questions before the FDA forces the answers on them.
HPA brings senior-led, audit-grade judgment to your combination product program so you can make defensible decisions early, build a submission that holds up under scrutiny, and move forward with a plan your team, leadership, and investors can stand behind.
If your combination product program requires broader support, we can extend the engagement into Regulatory Consulting Services or Clinical Trial Strategy & Execution, so your regulatory, clinical, and quality efforts stay aligned from strategy through execution.
