Healthcare & FDA Law Blog
Navigating FDA’s cGMP Standards for Dietary Supplement Manufacturers
Ensure your dietary supplement business stays FDA-compliant with this in-depth guide to cGMP standards under 21 CFR Part 111. Learn about ingredient testing, recordkeeping, quality control, and FDA enforcement actions to avoid penalties, recalls, and warning letters.
Mobile Health Apps Legal Compliance Essentials for FDA and FTC Standards
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, manage patient data securely, and market legally under federal and state laws.
Risk Management and Compliance for Direct-to-Consumer Genetic Testing Companies
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, manage genetic data privacy, and ensure truthful marketing claims to prevent regulatory fines and lawsuits.
FDA Guidance on Studying and Marketing Medical Devices – Part Two
The Food and Drug Administration has numerous guidance articles about premarket submissions for the developers of medical devices. We discuss steps three and four.
Legal and Compliance Strategies for Health Coaching Businesses
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 coaching business, protect against unlicensed practice claims, and market services within regulatory guidelines.
FDA Guidance on Studying and Marketing Medical Devices – Part One
The Food and Drug Administration has numerous guidance articles about premarket submissions for the developers of medical devices. We discuss steps one and two.
Advertising Compliance for Medical Devices: FTC and FDA Requirements
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 their making. The upshot is that promotional claims about medical devices, including advertising, must be truthful and not misleading. To achieve this, the FDA [...]
Healthcare Mergers and Acquisitions: Legal Considerations for Providers
Explore essential legal considerations for healthcare mergers and acquisitions, covering due diligence, regulatory compliance, and structuring agreements. Insights from Cohen Healthcare Law Group.
California’s “Physicians Make Decisions Act” Regulates the Use of AI in Insurance Decisions
California’s “Physicians Make Decisions Act,” effective January 1, 2025, requires human oversight of the use of artificial intelligence in medical treatments and decisions.
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