The FDA defines a combination product as a product comprising two or more regulated components, examples include a device combined with a drug, a device combined with a biologic, a biologic combined with a drug, and so on. The regulated components can be physically, chemically, or otherwise combined or mixed to produce a single entity, or the components can be combined within mutual packaging during the manufacturing and distribution processes.
The situation: a European medical device manufacturer wanted to submit a traditional 510(k) for its bone cement, which included an antibiotic. Because both the cement and the antibiotic are regulated components, the product met the definition of a combination product. This changed the avenue for submission.
RQMIS understands combination product submissions and has experience in both the medical device and the pharmaceutical industries. A manufacturer of a combination product has to comply with two Quality System Regulations (QSRs): 21 CFR 820, QSR for Medical Devices, and 21 CFR 211, Good Manufacturing Processes (GMP) for finished pharmaceuticals.
RQMIS advised the manufacturer to ensure that all formulation, labeling, testing, and pre-submission data was in line with the various regulations for both medical devices and pharmaceuticals, despite the medical-device nature of the product. In addition. RQMIS helped the manufacturer:
- Identify labs capable of performing relevant preclinical testing
- Review formulation, labeling, testing and verification plans for the product to ensure compliance with 21CFR820 and 21CFR211
- Determine FDA flexibility on antibiotic concentrations and tests through pre-submission
As the manufacturer is located outside of the U.S., RQMIS also acted as the manufacturer’s U.S. Agent. RQMIS was able to get this manufacturer’s combination product cleared in five months:
November: RQMIS 510(k) combination-product submission received by the FDA
January: RQMIS addresses FDA questions and requests for clarification
March: FDA clears combination product for sale in the U.S.