RQMIS

Combination Product Clearance

The Situation

A European medical device manufacturer sought FDA clearance through the traditional 510(k) pathway for a bone cement containing an antibiotic.

However, because the product combined a device (cement) and a drug (antibiotic), it was classified as a combination product, triggering more complex regulatory requirements across both medical device and pharmaceutical frameworks.

This created uncertainty around the appropriate regulatory strategy, documentation, and testing needed to meet FDA expectations.

The Solution

RQMIS developed a clear regulatory pathway tailored to combination product requirements, ensuring alignment across both device and pharmaceutical regulations.

Guided preparation of formulation, labeling, and testing to meet dual regulatory expectations
Prepared the manufacturer for and supported FDA audit readiness
Ensured all pre-submission data and documentation were complete and compliant

With a fully aligned strategy and submission, the manufacturer successfully obtained FDA clearance within five months.

Medical Device–Drug Combination Product Clearance

The FDA defines a combination product as one composed of two or more regulated components—such as a medical device combined with a drug or biologic—whether physically integrated or packaged together.

A European manufacturer sought FDA clearance through the traditional 510(k) pathway for a bone cement containing an antibiotic. Because the product combined a device and a drug, it qualified as a combination product, significantly altering the regulatory pathway and requirements.

This classification introduced added complexity, requiring compliance with both:

21 CFR Part 820 (Quality System Regulation for medical devices)
21 CFR Part 211 (Good Manufacturing Practices for pharmaceuticals)

RQMIS leveraged its expertise in both medical device and pharmaceutical regulations to guide the manufacturer through a dual-compliance strategy:

Ensured all formulation, labeling, testing, and pre-submission data aligned with both device and drug regulatory requirements
Identified and coordinated with qualified laboratories for preclinical testing
Reviewed and refined verification and validation plans to meet 21 CFR 820 and 21 CFR 211 standards
Engaged the FDA through a Pre-Submission process to clarify expectations, including flexibility around antibiotic concentrations and testing requirements
Acted as the manufacturer’s U.S. Agent, managing FDA communications and submissions

The Outcome

November: 510(k) combination product submission received by the FDA
January: FDA questions addressed efficiently
March: FDA clearance granted

The manufacturer achieved FDA clearance in just five months, successfully navigating the complexities of a combination product submission.

Straight Talk

Combination products don’t fail because of science—they fail because of regulatory misalignment.

RQMIS bridged device and pharmaceutical requirements, aligned with the FDA early, and kept the process moving—turning a complex pathway into a fast, successful clearance.

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

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