1. FDA Status
Healia has NOT been evaluated, cleared, or approved by the U.S. Food and Drug Administration (FDA). Healia is not a medical device, Software as a Medical Device (SaMD), or clinical decision support system as defined by the FDA.
Healia is classified as a general wellness and health education application that provides informational content to help users make their own informed health decisions. Healia does not claim to diagnose, treat, cure, or prevent any disease.
2. Supplement and Product Disclaimers
Product recommendations made through the Healia Service may include dietary supplements, over-the-counter medications, and health-related products.
- Statements regarding dietary supplements have not been evaluated by the Food and Drug Administration
- Dietary supplement products are not intended to diagnose, treat, cure, or prevent any disease
- OTC medication recommendations are based on generally accepted uses as described on product labeling and publicly available clinical guidelines
- Healia does not manufacture, distribute, or sell any health products
- Product availability, pricing, and formulations may vary and are subject to change by manufacturers and retailers
3. International Users
Healia is available globally. While our company is US-based, our platform serves users worldwide. Health product regulations, availability, and naming conventions vary by country. If you are using Healia outside the United States:
- Product recommendations may not be available or approved in your country
- Regulatory status of suggested products may differ in your jurisdiction
- Traditional and herbal remedy suggestions are based on published research but may not be approved by your local regulatory authority
- You are responsible for verifying that any recommended product is legal and available in your country
4. AI Regulatory Status
Healia's AI systems are designed to provide health-related information and education. Under current U.S. regulatory frameworks:
- Healia is not intended for use in the diagnosis or treatment of disease, and therefore is not classified as a medical device under 21 CFR 820
- Healia does not meet the FDA's definition of Software as a Medical Device (SaMD) as defined in the FDA's 2017 Digital Health Innovation Action Plan
- Healia is not a Clinical Decision Support (CDS) system that is intended for use by healthcare professionals in clinical settings
If regulatory requirements change, Healia will update its practices and disclosures accordingly.
This notice should be reviewed by regulatory counsel before publication.
