Combination Product Clearance

The Situation

A European medical device manufacturer wants to submit a traditional 510k FDA for its bone cement, which includes an antibiotic. Because both the cement and the antibiotic are regulated components, the product met the definition of a combination product.

The Solution

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. After correctly approving the different FDA audits, having previously carried out their preparation. The manufacturer was able to submit the documentation and gained FDA clearance in five months.

RQMIS Gets Medical Device-Drug Combination Product Clearance

The FDA defines a combination product as a product comprising two or more regulated components, examples include a medical device combined with a drug, a medical 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) FDA 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 FDA submission.

RQMIS understands medical device-drug combination product submissions and has experience in both the medical device and the pharmaceutical industries. A manufacturer of a medical device-drug 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 provided consulting support to 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 US, RQMIS also acted as the manufacturer’s US 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 related to the 510(k) FDA medical device submission.

March: FDA clears combination product for sale in the US.

Are you developing a medical device-drug combination product? Do you need help with the 510k FDA clearance?

Do you know what’s needed to get a quick 510(k) FDA clearance?

RQMIS Inc. can help you through each and every stage of the development process for a medical device-drug, from determining the extent of premarket testing to drafting documents for submission and getting the FDA clearance. Our 510(k) submissions expert can help you to achieve the 510(k) FDA clearance for your medical device.

Contact RQMIS at info@rqmis.com, call us at (978) 358-7307, or just click the Contact button below.

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