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Mobile health apps must comply with FDA regulations, HIPAA privacy laws, and FTC advertising guidelines to avoid enforcement actions. Learn how to determine if your app is a medical device, [...]

The Food and Drug Administration regulates dietary supplements by sending out warning letters and enforcing those letters. FDA also provides guidance in many forms, including alerts and notices.

Direct-to-consumer genetic testing companies must navigate complex FDA regulations, HIPAA compliance, and state laws to avoid enforcement actions. Learn how to structure your business legally, [...]

The Food and Drug Administration has numerous guidance articles about premarket submissions for the developers of medical devices. We discuss steps three and four.

Health coaching businesses must comply with state licensing laws, corporate practice of medicine rules, HIPAA, and FTC regulations when offering services. Learn legal strategies to structure your [...]

The Food and Drug Administration has numerous guidance articles about premarket submissions for the developers of medical devices. We discuss steps one and two.

The Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) finely regulate the promotion compliance of medical devices—both in terms of the claims made and in the manner of [...]