Most sponsors do not realize their mistake until after the FDA informs them. Drug-device combinations face overlapping FDA Center jurisdictions (CDER + CDRH). Mis-classified Primary Mode of Action triggers full resubmission, 12–18 month delays, and 7-figure rework.
Our solution
We will help determine which lead center applies to your company, assist with the design of your combination product quality management system under 21 CFR Part 4 (a) (b), and assist with managing both the CDER submission via IND, NDA or BLA or the CDRH submission via /IDE/PMA or 510(k) pathways concurrently.We also engineer the RFD strategy, design control documentation aligned to 21 CFR Part 4, and Pre-Sub package to lock in your Primary Mode of Action before submission. Single dossier, single answer, zero rework.
Process
How we run this engagement.
Discovery
Free 30-min consult on classification risk
RFD Strategy
Lock the Primary Mode of Action
Design Controls
21 CFR Part 4 documentation pack
Pre-Sub & Submission
Joint Center coordination
Lifecycle
PMS, change control, supplements
Drug-device, biologic-device & device-led combinations — RFD to PAI.
How we help
We author Request for Designation (RFD), align CMC and design controls, and harmonise QMSR with 21 CFR Part 4 streamlined cGMP.
