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
What You Need to Know? 👇
What are general wellness products under FDA’s policy for low risk devices?
General wellness products are products intended for maintaining or encouraging a healthy lifestyle that present low risk to users. They include exercise equipment, software programs, and other products commonly available from retail establishments that promote general health without treating specific diseases.
Does the 21st Century Cures Act affect how FDA regulates wellness software?
Yes, the Cures Act amended the FD&C Act to exclude certain software functions from the device definition. Software intended for maintaining or encouraging a healthy lifestyle that’s unrelated to diagnosis, cure, mitigation, prevention, or treatment of diseases is no longer considered a medical device.
What makes a general wellness product “low risk” according to FDA guidance?
A product is low risk if it’s not invasive, not implanted, and doesn’t involve technologies that pose safety risks requiring specific regulatory controls (like lasers or radiation). FDA also considers whether they actively regulate similar product types with special controls.
Can general wellness products make disease-related claims without FDA oversight?
Yes, but only specific types. Products can claim to help reduce disease risk or help living well with chronic conditions as part of a healthy lifestyle, provided the lifestyle-disease connection is well-established in peer-reviewed literature or professional organization statements.
What regulatory requirements does FDA not intend to enforce for qualifying general wellness products?
FDA won’t examine compliance with registration and listing, premarket notification, labeling requirements, quality system regulations, and medical device reporting requirements for products meeting their low risk general wellness criteria under this enforcement discretion policy.
How can manufacturers determine if their product qualifies under the general wellness policy?
Manufacturers should use FDA’s framework: confirm the product has general wellness intended use, verify it’s low risk (non-invasive, non-implanted, no special safety concerns), and review the guidance examples. Products must meet both general wellness use and low risk criteria.
What You Need to Do 👇
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