Labeling – General and Special Medical Devices Requirements

The FDA’s requirements for medical device labeling range from the typical general requirements down to very specific information about an individual product. Labeling actually covers a range of information, much more than people realize. For example, issuing a letter to customers about your product is labeling. What the letter says may throw you into a whole set of other regulatory requirements that FDA enforces rigorously. The general requirements fall into basic categories, but even those labeling distinctions may change. It is up to you to figure out when those changes take effect and drive what you must say. Some types of devices have very specific labeling requirements, such as hearing aids. The relatively recent implementation of the Unique Device Identifier (UDI) labeling requirement requires a precise identification of a device. Labeling also covers how you advertise or promote a product. Those legal boundaries are not clear cut and the FDA can overstep its legal authority. Firms are beginning to stand their ground on what the FDA can and can’t do about labeling.

The FDA holds you strictly liable for all labeling requirements in terms of what it says, represents or implies and even how you manage your labeling with the public. If you have a labeling problem, the FDA will say that your product is “misbranded” and, therefore, violates federal law. Sometimes the violation is easy to figure out, other times it is not. You need to go beyond the labeling regulations found in the regulations. You should be looking at what the FDA calls labeling, what it requires in certain circumstances and what you need to do in the future to prevent your labeling from violating FDA’s legal requirements. In some cases, the FDA’s treatment of labeling can be esoteric. You need to sensitize yourself to the FDA’s interpretation of labeling and how it watches what you do with labeling. Sometimes what someone else says about your product becomes your labeling and responsibility. Taking legal action for misbranding charges is relatively easy for the FDA, so it does not hesitate to go after you for those types of violations.

Areas Covered in the Session :
What constitutes labeling
Basic labeling for all devices
Prescription labeling
Consumer labeling
Customer letters treated as recalls
Unique Device Identifier
Device Sales and Promotion

Who Will Benefit:
Regulatory Affairs Departments
Quality Assurance Departments
Sales and Marketing Departments
In-house Legal Counsel for FDA law and product liability
Domestic Manufacturers
Foreign Manufacturers
Initial Importers

Casper E. Uldriks

Casper (Cap) Uldriks brings over 32 years of experience from the FDA. He specialized in the FDA’s medical device program as a field investigator, served as a senior manager in the Office of Compliance and as an Associate Center Director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements. He is recognized as an exceptional and energetic speaker. His comments are candid, straightforward and of practical value. He understands how FDA thinks, operates and where it is headed. Cap is the President of Encore Insight LLC, a consulting and training service for FDA law and operations.

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