FDA (CDRH)
GUIDANCE FINAL
General Wellness: Policy for Low Risk Devices: Guidance for Industry and Food and Drug Administration Staff
Published: 1/6/2026Detected: 3/25/2026
Summary preview
Clarifies FDA’s approach for “General Wellness” low-risk device oversight, outlining the premarket pathway and expectations for devices that may be eligible for reduced regulatory burden.
Get the full analysis, free
Create a free account to see the complete summary, key takeaways, and why this matters for your products, and to get alerts like this by email.
Create free accountmanufacturing
quality
clinical
safety
labeling
#general wellness
#low risk devices
#premarket
#device classification
#intended use
Official Source Document Source Verified
Access the original document directly from FDA CDRH.
More from FDA (CDRH)
- Robotically-Assisted Surgical Devices - Premarket Submissions: Draft Guidance for Industry and Food and Drug Administration Staff9/25/2026
- Electronic Submission Template for Premarket Approval Applications (PMA): Draft Guidance for Industry and Food and Drug Administration Staff9/18/2026
- Dental Curing Lights - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff9/2/2026
- Dental Composite Resin Devices - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff9/2/2026
- Applying Human Factors and Usability Engineering to Medical Devices: Guidance for Industry and Food and Drug Administration Staff8/3/2026