General Wellness Products: Policy for Low Risk Devices and Software Functions
This guidance clarifies FDA's policy regarding low-risk general wellness products, defining which products are considered general wellness products and when they fall outside FDA's regulatory oversight. It applies to products that: 1. Are intended for general wellness use only 2. Present a low risk to users' safety 3. May include exercise equipment, audio recordings, video games, and software programs
Recommended Actions
- Evaluate if your product meets both criteria:
- Intended only for general wellness use
- Presents low risk to users
- Review product claims to ensure they:
- Focus only on general wellness or
- Make appropriate disease-risk reduction claims with proper scientific backing
- Assess product risk by confirming:
- Non-invasive nature
- No implantation
- No high-risk technologies used
- Document scientific evidence supporting any disease-related claims
- Review similar products to check if CDRH actively regulates them
- Ensure marketing materials and labeling align with general wellness claims guidelines
- Implement appropriate quality controls even if product falls under general wellness category
- Maintain records demonstrating how product meets general wellness criteria
Key Considerations
Software
- Software functions intended for maintaining or encouraging healthy lifestyle unrelated to diagnosis, cure, mitigation, prevention, or treatment of disease are not considered devices
- Software must be low risk and not pose safety concerns if specific regulatory controls are not applied
Labelling
- Claims must be limited to general wellness or healthy lifestyle
- Disease-related claims must only reference well-understood associations between healthy lifestyle and disease risk reduction
- Claims should be expressed as “may help to reduce the risk of” or “may help living well with”
Safety
- Products must not be invasive
- Products must not be implanted
- Products must not involve technology that poses risks requiring specific regulatory controls
- Products must not use technologies like lasers or radiation that could pose safety risks
Other considerations
- Products must relate to maintaining/encouraging general health or healthy activity
- Products can address weight management, physical fitness, relaxation, mental acuity, self-esteem, sleep management, or sexual function
- Disease-related claims must be based on peer-reviewed publications or official healthcare professional organization statements
Relevant Guidances
- Policy for Device Software Functions and Mobile Medical Applications
- Content of Premarket Submissions for Device Software Functions
- Off-The-Shelf Software in Medical Devices: Documentation Requirements for Premarket Submissions
- Changes to Medical Device Definition for Software Functions Under the 21st Century Cures Act
Related references and norms
- 21 CFR Part 807: Registration and listing requirements
- 21 CFR Part 801: Labeling requirements
- 21 CFR Part 820: Quality System regulation
- 21 CFR Part 803: Medical Device Reporting requirements
Original guidance
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