Combination Products
Drug + Device. Biologic + Device. Borderline Products, Structured and Defensible.
Combination products fail when teams treat them like “just a device” or “just a drug.” We help you define Primary Mode of Action (PMOA), align to the lead center, bridge QMS/cGMP obligations, and build an evidence and labeling plan that works across components—without duplicative chaos.
Jurisdiction clarity
PMOA and lead center aligned early to prevent rework.
Unified quality
Bridge QMS and cGMP with practical interface controls.
Human factors
Use-related risks proven—not assumed—across steps.
One story
Cross-component evidence + labeling that reads cleanly.
Why delays happen
Why combination products get stuck
Combination products are about interface risk: drug/device interactions, labeling consistency, manufacturing controls, and who “owns” what. The most common delays come from unclear PMOA/lead center strategy, mismatched quality systems, incomplete usability support, and submissions that don’t tell a coherent cross-component safety story.
PMOA decisions drive everything
- Lead center alignment (CDER/CDRH/CBER) and pathway structure
- How your evidence plan is organized across components
- What “success” looks like for reviewer expectations
Quality obligations overlap
- Device QMSR/ISO 13485 + drug cGMP + 21 CFR Part 4 streamlined requirements
- Change control and supplier controls at the interface
- Document control and traceability across components
Labeling must be unified
- IFU, warnings, claims, and instructions aligned across channels
- One “voice” across drug/device elements
- Consistency with human factors and risk controls
Human factors is critical
- Dose delivery and user steps must be demonstrated
- Use-related risks tied to labeling and mitigations
- HF evidence packaged for reviewer readability
Programs & pricing
Fee schedule effective October 1, 2026 (FY2027)Combination product programs
Clear engagements for complex products—strategy first, then controlled execution. Fees quoted as “from” reflect a minimum scope and are confirmed in writing after triage.
01 — PMOA & pathway strategy sprint
- PMOA & Pathway Strategy Memo$9,500
- FDA Pathway & Readiness Diagnostic (device-led only)$6,500
- 513(g) Request for Information$4,500
- PMOA analysis + pathway recommendation (device-led vs drug-led vs biologic-led)
- Component mapping: what is regulated as what, and why
- Evidence roadmap: bench/biocomp/usability + drug/biologic elements where applicable
02 — RFD / lead center alignment
- Request for Designation — strategy + drafting$12,500–$22,500
- Pre-RFD informal submission$7,500
- Positioning memo only (no filing)$6,500
- RFD strategy + drafting support (when appropriate)
- Regulatory positioning narrative + risk framing
- Meeting prep support and post-feedback action plan
03 — QMS / cGMP bridging & controls pack
- Full bridging + core SOP set$18,500–$45,000
- Gap assessment only (no SOP build)$12,500
- Device-side QMSR gap analysis$9,500
- ISO 14971 risk management file$8,500
- Gap assessment: design controls, CAPA, complaints, change control, supplier controls
- Interface risk controls: compatibility, dose delivery, storage/handling, labeling control
- Core SOP set + templates to support audits and submissions
04 — Submission build
- Device-led combination 510(k)from $45,000
- Device-led combination De Novofrom $85,000
- Device constituent-part workstream (drug/biologic-led)from $38,500
- Human factors / usability engineering package$12,500–$22,500
- Deficiency / AI response drafting$4,500–$12,500
- Drafting + assembly with device and drug/biologic sections aligned
- Human factors integration across labeling, IFU, and use-related risk
- Response support for FDA questions across components
The full-build fee includes the ISO 14971 risk file, the human factors package, Small Business Determination filing, and labeling alignment across constituent parts.
Where we lead, and where we support
We lead device-led combination products end to end — PMOA, RFD, device constituent-part documentation, human factors, interface controls, and the submission itself. For drug-led and biologic-led products, we run the device constituent-part workstream and the Part 4 quality bridge alongside your CMC and clinical teams or your NDA/BLA counsel, rather than owning the whole application. Naming that boundary up front is how the interface stays clean.
Start async (preferred for scoping)
Share your component description, intended use, dose/delivery mechanism, current quality system, and any existing FDA correspondence. We’ll respond with a scoped plan and a PMOA read.
• Fee schedule effective October 1, 2026 (FY2027). Existing clients are held at prior-year pricing through their next renewal.
• Fees are for consulting services and document preparation. FDA user fees, laboratory testing, human factors study execution, and clinical costs are billed at cost and are separate.
• Final scope depends on component count, novelty, manufacturing maturity, and whether HF and clinical work is required. After triage, we provide a fixed or milestone quote.
• Ongoing coverage is available through the Device Growth Partner ($6,500–$11,000/mo) and Inspection-Ready ($12,000–$19,000/mo) programs.
Fit
Who we help
Teams navigating cross-center interfaces, interface risk, and quality system bridging.
Drug-device products
Pre-filled syringes, autoinjectors, inhalers, transdermal systems where device and drug must be evaluated together.
Biologic-device products
Delivery systems where PMOA, comparability, and quality systems need careful framing.
Borderline classification
Products where “is it a device?” or “is it a drug?” is unclear and an RFD strategy is necessary.
Human factors complexity
Use errors can lead to dose failures, contamination, or adverse events—HF must be designed and demonstrated.
Multi-center coordination
Teams navigating CDER/CDRH/CBER interfaces and needing clear ownership and documentation strategies.
Quality system gaps
Organizations with device QMS but no drug cGMP experience (or vice versa) needing practical bridging.
Process
How we run combination product engagements
Strategy → controls → submission, with clear handoffs and no duplicative work.
PMOA & lead center
Lock PMOA, map components to regulatory categories, and align pathway and lead center strategy.
Quality systems
Identify overlapping obligations, build interface controls, and create unified documentation that works for both sides.
Evidence & labeling
Coordinate testing, human factors, and labeling so components tell one coherent safety story.
Dossier & defense
Assemble submissions with clear component boundaries and support cross-center questions without confusion.
FAQs
Combination product FAQs
Straight answers for PMOA, RFD decisions, and quality bridging.
What’s the biggest mistake teams make with combination products?
Treating them as “device + some drug stuff” or “drug + some device stuff” without a coherent PMOA position and unified quality/evidence plan. This leads to mismatched documentation, unclear jurisdiction, and preventable delays.
Do we need an RFD for every combination product?
Not always. Many combination products have clear PMOA and established lead centers. RFD is most valuable when jurisdiction is unclear or when you need formal FDA input on classification. A Pre-RFD informal submission at $7,500 resolves a large share of cases without the full package — and the $9,500 PMOA memo will tell you which situation you are in.
Do you handle drug-led and biologic-led products too?
We run the device constituent-part workstream and the 21 CFR Part 4 quality bridge for drug-led and biologic-led products, working alongside your CMC, clinical, and NDA/BLA teams. We do not author the drug or biologic application itself. For device-led products we own the full submission.
Can we use the same quality system for device and drug components?
With proper bridging, yes. Under 21 CFR Part 4 you can operate a streamlined system based on either cGMP or the device QMSR, provided the specified provisions from the other are demonstrably satisfied. The work is identifying where the two overlap, where they diverge, and documenting interface controls that hold up in either kind of inspection.
Are these pricing ranges fixed?
The single-price items are fixed. The ranges are working bands — after a triage call we provide a fixed or milestone quote based on PMOA complexity, quality system maturity, component count, and submission pathway.