How to confirm a combination product to regulations in the US?

Companies who market or want to market a combination product in the US face specific challenges to get and keep their products regulatory compliant. Although no new requirements are added, the scope for conforming with the requirements has changed.

• What unfamiliar compliance requirements will traditional pharma companies face?

• And what unfamiliar compliance requirements will traditional device manufacturers face?

With 21 CFR 4 FDA introduced cGMP requirements for combination products. A combination product is a combination of two or three different types of the following regulated products: a biological product, a drug, or a medical device. In 21 CFR 3 FDA recognizes four types of combination products: single entity, co-packaged, cross-labelled, and (investigational) cross-labelled. FDA’s Office of Combination Products (OCP) classifies combination products for regulation, coordinates the regulations within FDA and is a resource for the industry.

Examples of combination products are prefilled syringe, insulin injector pen, metered dose inhaler, transdermal patch, drug eluting stent, pacing lead with steroid coated tip, catheter with antimicrobial coating, condom with spermicide, bone graft implant, and photodynamic therapy.

For manufacturers, in general, there are two ways to conform with the regulations:

  • Ensure conformity of the combination product by applying all cGMP regulations applicable to each of the parts.
  • Ensure conformity of the combination product by only applying the drug cGMP regulations (21 CFR 210 and 21 CFR 211), or by only applying the biologic cGMP regulations (21 CFR 600-680), or by only applying the device CGMP (QS) regulations (21 CFR 820), or by only applying the current good tissue practice requirements including donor eligibility requirements for HCT/P (21 CFR 1271). This is the so-called “streamlined approach”.

However, manufacturers must ensure the following. If parts - drug, biologic, device, and HCT/P (human cell, tissue, and cellular and tissue-based product) - are combined in a combination product, each individual part keeps its own cGMP requirements for conformance. The idea is that if any conflict or ambiguity appears, you follow the most specifically applicable regulation.

Depending on the primary mode of action (PMOA), the drug or device constituent of a combination product now got another regulatory and quality assurance status. The assignment of a combination product is based on its PMOA, which is the most important therapeutic action of a combination product. FDA assigns a manufacturer’s combination product to one of the following FDA divisions for taking the lead in approval, inspection, etcetera: Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER) or Center for Devices and Radiological Health (CDRH).

If you are interested in whether your combination product will face specific regulatory challenges in the US? Contact Combisolve. Combisolve is specialized in regulatory compliance and quality assurance for biologic/drug/device combination products. Combisolve is launched to combine expertise by Qserve and Vormation. The focus is on the medical device component, including the medical device interrelations between the biologic, drug and medical device in the combination product, and concerns the US combination products regulatory compliance requirements. The solutions of Combisolve comprise the specific expertise and activities required for application in combination products pre-market and post market situations. Want to read more details and examples? Download the brochure.


Fred van Ommeren


Written by: Fred van Ommeren, Executive Director at Combisolve.



Post date: April 03, 2017
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