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The FDA’s Digital Health Center of Excellence (DHCoE) is rapidly becoming a central piece of the regulatory landscape for digital health technologies within the medical device world. If your company develops software as a medical device, connected health tools, AI/ML-enabled systems, or other digital health technologies, you need to understand what DHCoE means and how it may impact your regulatory strategy. Whether you are designing your next-generation device or preparing for a submission,...

What to stop saying, where brands get sloppy, and how to protect your business If you sell dietary supplements, your biggest regulatory risk is rarely the ingredient panel. It is your claims. The FDA does not need your product to cause harm to act. If your labeling, website, social media, Amazon listing, influencer scripts, or customer testimonials suggest your supplement can diagnose, treat, cure, mitigate, or prevent a disease, you have entered drug territory. That is where warning letters,...

What Cosmetic Brands and Industry Leaders Need to Know Right Now The U.S. Food and Drug Administration just rolled out important updates to its Cosmetics Direct electronic submission portal and supporting materials designed to make the biennial renewal process for cosmetic product facility registrations clearer and more manageable. If your company manufactures, processes, distributes, or imports cosmetic products into the United States, this affects you. These updates come as cosmetic...