Bioelectronics Corp (BIEL)

[srinsocal]

Is a new 510(k) required for a modification to the device?

The RecoveryRX XTRA has the same electronics, battery, off/on function as the Cleared RecoveryRx device. The change is in the Antenna shape, originally circular to rectangular to better fit surgical wounds.

FDA
Is a new 510(k) required for a modification to the device?

Introduction

Medical devices undergo frequent modifications to their design and materials due to many things; changes in the supply chain, continuous process improvement, or to keep pace with technological innovations that can improve how these devices work in a clinical setting. Major modifications to the device likely require premarket review by the FDA, while minor changes likely do not.

A premarket notification (510(k)) is required when a legally marketed device subject to 510(k) requirements is significantly changed or modified in design, components, method of manufacture, or intended use. Significant changes or modifications are those that could significantly affect the safety or effectiveness of the device, or major changes or modifications in the intended use of the device (21 CFR 807.81(a)(3)).

The regulatory language provides essential flexibility instead of rigidly defining the types of changes that require FDA review. Appropriate application of this flexibility enables innovation and ensures Agency oversight only when necessary. For some types of changes to a device, the Agency believes that submission of a new 510(k) is not required and that reliance on existing Quality System (QS) requirements (21 CFR 820) is the least burdensome approach to reasonably assure the safety and effectiveness of the changed device.

https://cacmap.fda.gov/medical-devices/premarket-notification-510k/new-510k-required-modification-device#:~:text=Major%20modifications%20to%20the%20device%20likely%20require%20premarket,design%2C%20components%2C%20method%20of%20manufacture%2C%20or%20intended%20use.