Experts Say Combination Products Can Cause Unique Regulatory Headaches

Drug-device combination products can pose cumbersome regulatory challenges for companies, say regulatory experts, primarily because the product has to comply with two complicated regulatory systems that are not designed to work together.

One office — the FDA’s Office of Combination Products (OCP) — has the job of determining which center — CDER, CDRH or CBER — will serve as the lead, applying its specific regulations and procedures, while the other(s) provide a consulting role.

To assist with that decision, the FDA lists three categories of combination products:

• Products that have a drug and device component fully integrated into a single product, such as a drug-eluting stent, pacing lead with steroid-coated tip or insulin injector pen;
• Products that have both drug and device components packaged together but not integrally, such as first-aid kits containing gauze and antibiotic ointments, or a drug or vaccine vial packed with a delivery device; and
• Two products sold separately but cross-labeled for use, such as a drug requiring a diagnostic test to determine whether the drug is necessary and a diagnostic test with labeling indicating use of that drug, like a photosensitizing drug and activating light.

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