Combination Products Regulatory Toolkit
PMOA determination, regulatory strategy, drug-device design controls integration, cGMP compliance checklist, constituent part agreement, and RFD package templates for FDA combination product programs.
What You Get
Combination Product Classification and PMOA Determination Template
Structured framework for determining whether your product is a combination product and identifying the primary mode of action (PMOA). Covers the three-part combination product definition test, the PMOA determination methodology per 21 CFR 3.2(m), the Request for Designation (RFD) process when PMOA is unclear, and the lead center determination that drives your submission pathway.
Combination Product Regulatory Strategy Memo
Template for documenting your combination product regulatory strategy including lead center, primary submission pathway, cross-labeling requirements, and the cGMP framework that applies (device QSR vs drug CGMP vs biologics CGMP). Covers the current good manufacturing practice (CGMP) flexibility provisions in 21 CFR Part 4 for device-led and drug-led combination products.
Drug-Device Combination Product Design Controls Integration Template
Framework for integrating FDA drug and device design control requirements for drug-device combination products. Covers how 21 CFR 820.30 device design controls align with ICH Q8-Q10 pharmaceutical development principles, the shared design history file structure, and the additional design inputs required for drug component performance in combination products.
Combination Product Constituent Part Agreement Template
Quality agreement template for drug-device combination products where device constituent and drug constituent are manufactured or developed by separate entities. Covers responsibility allocation, change notification requirements, cross-constituent testing obligations, and the regulatory submission coordination requirements that prevent inconsistent claims across the combination product application.
cGMP Compliance Checklist for Combination Products (21 CFR Part 4)
Compliance checklist for the streamlined combination product CGMP framework. For device-led products: confirms cQSR/CGMP compliance plus applicable drug CGMP provisions. For drug-led products: confirms drug CGMP compliance plus applicable device QSR provisions. Covers the current good manufacturing practice (CGMP) flexibility pathway that avoids full dual-compliance.
Request for Designation (RFD) Package Template
Complete package template for submitting a Request for Designation to the FDA Office of Combination Products (OCP). Covers the product description, combination product definition analysis, PMOA argument, proposed lead center with supporting rationale, and the supplementary information package that reduces OCP review time and clarification requests.
FAQ
What makes a product a combination product?
A combination product is a product comprised of two or more regulated components (drug, device, and/or biological product) that are physically, chemically, or otherwise combined and produced as a single entity, co-packaged, or cross-labeled for co-use. Drug-eluting stents, prefilled syringes, and drug-delivery pens are common examples.
What does PMOA mean for combination products?
Primary Mode of Action (PMOA) determines which FDA center leads review of your combination product. A device PMOA routes to CDRH; a drug PMOA routes to CDER; a biological PMOA routes to CBER. The PMOA determination drives your submission type, cGMP requirements, and regulatory strategy.
What format are the documents?
All documents are editable Word and Excel templates ready for direct use.
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For informational purposes only. Not legal or regulatory advice. Legal