$347 — Premium Tier

Combination Products Regulatory Toolkit: FDA PMOA and cGMP Templates

Combination Products Toolkit — PMOA determination, regulatory strategy memo, drug-device design controls integration, constituent part agreement, cGMP compliance checklist, and RFD package template.

Get the Toolkit — $347

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What's Included

Combination Product Classification and PMOA Determination Template
Combination Product Regulatory Strategy Memo
Drug-Device Design Controls Integration Template
Combination Product Constituent Part Agreement Template
cGMP Compliance Checklist (21 CFR Part 4)
Request for Designation (RFD) Package Template

Benefits

PMOA determination framework with lead center routing logic
21 CFR Part 4 cGMP checklist avoids full dual-compliance burden
RFD package template reduces OCP clarification requests
Constituent part agreement covers FDA and EU MDR obligations between co-development parties

Is This For You?

This toolkit is designed for teams facing these challenges:

PMOA unclear causing submission to be routed to wrong FDA center
cGMP compliance unclear for drug-device combination under 21 CFR Part 4
No quality agreement covering cross-constituent testing and change notification
RFD package incomplete causing OCP review delay

Who This Is For

RA leads managing drug-device combination product programsRegulatory consultants supporting combination product submissions to OCPProduct development teams building prefilled syringe or drug-delivery device productsCompanies developing drug-eluting devices requiring PMOA determination

Frequently Asked Questions

What makes a product a combination product?

A product comprised of two or more regulated components (drug, device, biological) that are combined, co-packaged, or cross-labeled for co-use. Drug-eluting stents, prefilled syringes, and drug-delivery pens are common examples.

What does PMOA determine?

Primary Mode of Action determines which FDA center leads review: device PMOA routes to CDRH, drug PMOA to CDER, biological PMOA to CBER. This drives submission type, cGMP requirements, and regulatory strategy.

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Ready to Get Started?

Download immediately after purchase. All templates are editable Word and Excel files.

Get the Toolkit — $347

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