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Do I need FDA Approval for my app?

I want to make a Health Product! General Health Claims Is your product used to manage or improve any of these general health areas? stress & relaxation mental acuity sexual function Do I Need FDA physical fitness weight management Approval? personal appearance self-esteem Zz sleep management YES NO Medical Conditions Is your product intended use for a specific disease or medical condition? NO YES Chronic Conditions Is it chronic, and well understood that a healthy lifestyle choice reduces the risk or impact of the condition? Heart disease · Type 2 Diabetes High Blood Pressure YES NO Claim Is your claim clear that your product may help reduce the risk of, or ability to live well with your target condition? NO YES Safety Risk Does your product present a risk to the user's safety? Is it invasive, or does it use laser, radiation, or implants? Does the FDA regulate similar products? NO YES Your product falls under the guideline for a general wellness product. You won't need FDA approval. Your product does not fall under these guideline and may need FDA approval. Source For more information visit or download the PDF draft here:]17KY ayogo Leaders in patient engagement through social play™ · @ayogohealth Design by Ellena Lawrence ·

Do I need FDA Approval for my app?

shared by AyogoHealth on Feb 28
Using the recent ruling from the FDA this info-graphic provides a decision tree to help you determine whether your health app or health product will need to proceed through FDA approval.



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