Unlocking Regulatory Complexities
The key to combination product success
White Paper
Feb 01, 2019

This white paper explores medical device combination product strategies to improve the regulatory journey from classification to market clearance for sponsors. The shifting borders among traditional drugs, biologics, and medical devices are poised to produce safer and more effective combination products that offer new diagnostic and treatment options for patients.

These products consist of two regulated components, a drug and a medical device, which are combined to develop a single product. But such novel combination products pose numerous regulatory hurdles for sponsors, even when comprised of previously cleared components. Drug-device combination products are notably complex, particularly when it comes to designing clinical trials and preparing for regulatory review. Partnering with a contract research organization (CRO) with experience in planning and executing both medical device and drug trials can help sponsors navigate these hurdles.

This paper explores medical device combination product strategies IQVIA™ recommends to improve the regulatory journey from classification to market clearance for sponsors.

A growing market

The commercial market for drug-device combination products is expected to grow at a compound annual growth rate of more than 11 percent by 2019.1 There are a number of drivers behind this growth, primarily an emergent patient population with chronic diseases such as cardiovascular disease, diabetes, prostate cancer and others. Demand for minimally invasive surgeries and portable devices, such as inhalers and insulin injectors, is also fueling growth.

For regulatory purposes, the U.S. Food and Drug Administration (FDA) defines combination products as therapeutic and diagnostic products that combine drugs, devices or biological products.2 Many other regulatory authorities ranging from Japan’s Pharmaceuticals and Medical Device Agency (PMDA) and China’s State Food and Drug Administration (SFDA) to Canada’s Health Authority (Health Canada) and the European Medicines Agency (EMA) review and approve combination products via processes that differ from the FDA and from each other, even within EU member countries. While this paper focuses on the FDA requirements for combination products, IQVIA can provide counsel regarding the requirements crucial to clinical evaluations and timely market clearance globally.


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