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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 Relabelers Repackagers Initial Importers Distributors Consultants
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