Are you sure you know whether your new medical product is a drug, a device or a combination product?
With the FDA changing the way it classifies “close call” products — those somewhere between drugs, devices and combination products — you could find yourself on the wrong approval pathway after having spent tremendous amounts of effort.
This webinar will explain everything you must know about the new approaches the agency is adopting as a result of losing its appeal in Genus Med. Techs., LLC v. FDA, a case contesting the agency’s classification of a medical product as a drug rather than a device.
You need to understand the implications of this case and how it impacts your products so you can choose the correct approval pathway right away.
Using this case as context, Michael M. Gaba, vice chair of Polsinelli’s FDA practice, will share how you can evaluate your product thoroughly for its regulatory status, without prejudging it or jumping to conclusions. He’ll walk you through the FDA’s current and most likely next steps so you know what it means for your new product’s approval process and can stay ahead.
- The statutory definitions of medical devices and drugs, how they are similar with respect to intended use claims and how they are different with respect to how each achieves its primary intended use
- How the FDA put itself in a position to be sued over its decision to regulate a product as a drug and not a device
- The regulatory process the FDA has embarked upon to address the court decision, which may create concerning ambiguities for regulatory professionals
- How to identify product types that may be subject to this regulatory process, including imaging agents and combination products, i.e., drugs and devices
- The regulatory challenges and implications of switching from drug status to medical device status, including adjustments to quality system requirements and the burdensome prospect of needing to maintain different regulatory standards for the same product intended for the U.S. market versus the rest of the world
One thing is certain in all of this: the FDA is rethinking its classification process. Stay on top of the drug vs. device changes with this webinar.
Who Will Benefit:
- Vice presidents of regulatory affairs
- Regulatory department personnel
- Manufacturers of drug/device combination products