Key Takeaways - FDA’s 2026 guidance clarifies when digital health tools fall outside device regulation. Updated policies for clinical decision support (“CDS”) software and general wellness products provide clearer, more...more
2/5/2026
/ Digital Health ,
Food and Drug Administration (FDA) ,
General Wellness Devices ,
Healthcare ,
Medical Devices ,
Medical Software ,
Mobile Health Apps ,
New Guidance ,
Regulatory Oversight ,
Regulatory Requirements ,
Risk Management ,
Software ,
Transparency ,
Wearable Technology
Key Takeaways - The Declaration. Secretary Kennedy’s declaration concludes that pediatric gender-affirming care does not constitute a “safe and effective treatment” and that practitioners who furnish such services fall...more
1/22/2026
/ Centers for Medicare & Medicaid Services (CMS) ,
Children's Health Insurance Program (CHIP) ,
Conditions of Participation (CoP) ,
Department of Health and Human Services (HHS) ,
FDA Warning Letters ,
Gender Identity ,
Health Care Providers ,
Healthcare Facilities ,
Hospitals ,
Medicaid ,
Medicare ,
OCR ,
OIG ,
Pediatrics ,
Proposed Rules
Key Takeaways - FDA delivered its first assessment of PFAS in cosmetics. Issued on December 29, 2025, the statutory deadline under MoCRA, the report is the first federal assessment of PFAS in cosmetic products and establishes...more
1/15/2026
/ Consumer Product Companies ,
Cosmetics ,
Environmental Policies ,
Food and Drug Administration (FDA) ,
Modernization of Cosmetics Regulation Act of 2022 (MoCRA) ,
New Legislation ,
PFAS ,
Regulatory Requirements ,
Reporting Requirements ,
Retailers ,
State Bans ,
Toxic Chemicals
Key Takeaways - FDA evaluates direct-to-consumer ads based on the overall impression conveyed to consumers. Visuals, graphics, and on-screen text can equally contribute to an ad’s message. SUPERs function only as secondary...more
Key Takeaways - FDA oversight of AI mental health tools is accelerating. The Digital Health Advisory Committee’s (“DHAC’s”) November 2025 meeting highlights FDA’s increased attention to digital health technologies such as...more