FDA published a final rule, which goes into effect the first of September, to amend its “intended use” regulations.

In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences about the implications of FDA’s final rule on intended use, manufacturer’s objective intent, and the role that it has with labeling.

• When Mike and Jon refer to labeling, they are talking about the content of the label - the words used and claims made.
• High-level labeling describes intended use, indications for use, and label claims. Low-level labeling includes directions for use and package inserts. A claim is a claim whether put in high- or low-level labeling.
• High- and low-level labeling can be leveraged as a strategic, competitive advantage to minimize or streamline regulatory burden, which means how much effort and evidence is needed to go through the FDA and put on the market.
• Intended use focuses on a device (what it does, how it works, and what is its mechanism of action). Indications for use focuses on the patient (what illness, injury, disease, or condition is the device intended to prevent, diagnose, or treat).
• Why do we need a new rule about intended use? The intended use rule is important for medical device manufacturers because labeling is not limited to what they say or print.
• The root cause for the rule relates to manufacturers’ saying or claiming one thing, but inferring and implying another thing. FDA does not regulate, at least not yet, the names of medical devices.
• Manufacturer's Objective Intent: If manufacturer knows or has knowledge of facts that product, device, or drug would be used for conditions or purposes other than what is advertised/claimed, manufacturer may need to provide adequate labeling.
• Manufacturers also need to consider product liability and reimbursement implications of a device being used for purposes other than what’s on the label.

“When we refer to labeling, at least when I refer to it, I’m not talking about the sticky piece of paper that we stick on a package or in a box that a medical device comes in, nor am I talking about the graphics that go onto that label.” Mike Drues

“There have been numerous and continues to be numerous warning letters, recalls, etc, etc, etc, that are strictly related to content or lack thereof or misinformation that’s on labeling.” Jon Speer

“FDA does not regulate, at least not yet, the names of medical devices. So, you can embed a claim in the name of your device without it being subject, at least directly, to FDA regulation.” Mike Drues

“Don’t just focus on what you say in your labeling, also consider what you don’t say and how you don’t say it.” Mike Drues

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FDA - Center for Devices and Radiological Health (CDRH)

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