Need Help With OCP On A Combination Product?

Published on January 29, 2016
Categorized as Submissions

Avoiding a shipwreck after a three hour tour

A client came to us wanting to come to the U.S. market with a series of wound dressings and wanted to impregnate them with a variety of active moieties. We brought them to Office of Combination Products (OCP) to cast their vision for the product line and to explain our strategy that some wound dressings are like a simple Band-Aid®-like product at one end of the medical device spectrum while others are drug delivery product like a transdermal patch at the other end of the spectrum. We argued that some dressings that were somewhere at the middle of this continuum should be treated by OCP as medical device.  We worked with OCP in a Pre-RFD meeting to understand how to best position our Request for Designation (RFD) for success in future product submissions.

 

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