Faqs

In 2016, the FDA determined that certain general wellness products do NOT require FDA Clearance or 510(k) Clearance. Instead, these devices are simply “registered” with the FDA as General Wellness Products. The Center for Devices and Radiological Health (CDRH) defines general wellness products as products that meet the following two factors: (1) intended for only general wellness use and (2) present a low risk to the safety of users and other persons. The new policy states that:

“CDRH does not intend to examine low risk general wellness products to determine whether they are devices within the meaning of the FD&C Act or, if they are devices, whether they comply with the premarket review and post-market regulatory requirements for devices under the FD&C Act and implementing regulations, including, but not limited to: registration and listing and premarket notification requirements (21 CFR Part 807); labeling requirements (21 CFR Part 801 and 21 CFR 809.10); good manufacturing practice requirements as set forth in the Quality System regulation (21 CFR Part 820); and Medical Device Reporting (MDR) requirements (21 CFR Part 803).”

The SmartSun® Therapy Device (OvationULT) is registered under FDA 21 CFR 890.5500 REN#3010627475.