US FDA centralizes effort to address combination product issues

By Stewart Eisenhart, Emergo Group

US medical device and pharmaceutical regulators are launching a new committee to more comprehensively address policy and implementation challenges associated with combination products.

According to the Food and Drug Administration’s FDAVoice blog, the new Combination Products Policy Council will oversee product and policy issues involving drug-device combination products as well as cross-labeled products and classifications. Since premarket reviews of combination products typically require input from more than one FDA division, which can complicate review processes, the Combination Products Policy Council will be vested with decisive authority for these products.

Although the new council will not supersede the FDA’s existing process for premarket review of combination products, the council will have the authority to resolve any issues that may (and often do) arise between different FDA centers for devices, pharmaceuticals and biological regarding review, classification and clearance or approval of such products.

Formation of the Combination Products Policy Council comes after the FDAannounced plans to apply “lean management process mapping” to combination product reviews, which entails examining existing agency practices for how it reviews such products and then developing a new review process that “eliminates waste and maximizes value.”

For combination product manufacturers facing FDA classification and other challenges due to the complex nature of their submissions, a more centralized and coordinated regulatory framework should hopefully help reduce complexities and delays associated with bringing these products to market.

Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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