Digital Health Regulations 101: FDA vs. Wellness

• ​Michael Martinelli, JD, MS, MS is the Founding Director of Government at Standard Care and Principal at Epiphron Group LLC‍
• ​Mike holds a JD with a concentration in health law and two MS degrees in Biomedical Sciences & Public Policy.

• ​Ryan Stellar is the CEO & Co-founder of Standard Care
• ​Agenda: A brief overview of FDA medical device regulation. ​A discussion on navigating intricate boundaries of medical device regulation vs. wellness technologies
• ​Audience: ​Virtual care providers, digital health, wellness, DTx companies that are developing their regulatory strategies.
• ​Format: ​Interactive presentation, ​20mins of Q&A; FAQs welcome

Handouts:

• Guidance DSF MMA
• FDA Guidance on General Wellness: Policy for Low Risk Devices
• Skating the line between general wellness products and regulated devices: strategies and implications‍
• FDA regulatory pathways for medical devices

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