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Here’s why you need legal review of any information your healthcare company puts out on the Web: advertising claims can not only hurt, they can destroy your healthcare company.

The FDA examines whether medical devices comply with the regulations of the Food, Drug, and Cosmetic Act. Two of the most common violations medical device companies are charged are adulteration [...]

As more artificial intelligence products become available, the FDA is reevaluating its approval criteria. For now, De novo approval and 501(k) are being used along with premarket approval.

Does FDA deem your product to be a medical device, or is it just a consumer product that would not be regulated by FDA? Here are basic steps you can take to work through the puzzle.

The best way to select a healthcare lawyer or FDA attorney (or FDA regulatory consultant) for legal advice about your health and wellness service, practice, facility, or product, is to follow [...]