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Combination Products, FDA Jurisdictional Issues, FDA Postmarket Compliance Issues

Advances in medical technology have led to the development of products that are a combination of drugs, biological products, and devices — or products that may have more than one mode of action. The path to bring to market a combination product is more complex than usual. 

To streamline the premarket review process, we develop the scientific and regulatory arguments necessary to advocate for the most favorable jurisdictional assignment, and manage intercenter interactions to clarify study requirements. We also routinely assist with good manufacturing compliance, adverse event reporting, patent listing issues, and myriad other issues related to combination products.

Once the lead office is identified and the product approved, we assist clients in navigating the applicable requirements for each component and the product as a whole, e.g., whether to file an adverse event report or a medical device report, whether drug good manufacturing practices or the quality system regulation apply, how to report a recall, etc.



Representative experience

We have filed numerous RFDs that successfully persuaded FDA to regulate our client’s device-drug combination product in the device center.

One of our partners was invited by the FDA to speak at an agency workshop on the regulation of innovative drug delivery systems.

Another of our partners, during his time as an FDA associate counsel, was an advisor to the chief ombudsman on combination product matters.

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