Post

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

  1. Evaluate if your product meets both criteria:
    • Intended only for general wellness use
    • Presents low risk to users
  2. Review product claims to ensure they:
    • Focus only on general wellness or
    • Make appropriate disease-risk reduction claims with proper scientific backing
  3. Assess product risk by confirming:
    • Non-invasive nature
    • No implantation
    • No high-risk technologies used
  4. Document scientific evidence supporting any disease-related claims
  5. Review similar products to check if CDRH actively regulates them
  6. Ensure marketing materials and labeling align with general wellness claims guidelines
  7. Implement appropriate quality controls even if product falls under general wellness category
  8. 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

  • 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

  • General Wellness Products: Policy for Low Risk Devices and Software Functions
  • HTML / PDF
  • Issue date: 2019-09-27
  • Last changed date: 2019-09-26
  • Status: FINAL
  • Official FDA topics: Medical Devices, Digital Health, Premarket
  • ReguVirta summary file ID: 6d9a4896f78c623e8fc5e206c0de334d
This post is licensed under CC BY 4.0 by the author.