Reclassification of Non-Invasive Bone Growth Stimulators
AI-generated summary for informational purposes only. Not legal advice. See the original source for the authoritative text.
This rule changes how non-invasive bone growth stimulators are classified, moving them from class III to class II. This means they will no longer need the stringent premarket approval but instead require premarket notification, simplifying the process for companies. It aims to improve market access and availability by reducing regulatory hurdles.
AI-generated summary. May contain errors. Refer to official sources for legal decisions.
Key Changes
- Reclassification of the devices from class III to class II.
- Premarket notification required instead of premarket approval.
- Special controls established for safety and effectiveness.
Obligations
What this law requires
Manufacturers of non-invasive bone growth stimulators must submit a premarket notification (510(k)) to the FDA prior to marketing their device.
Manufacturers must ensure their non-invasive bone growth stimulators adhere to special controls established by the FDA to provide reasonable assurance of safety and effectiveness.
Manufacturers must conduct non-clinical performance testing to verify and validate thermal safety and thermal reliability of their non-invasive bone growth stimulators.
Manufacturers must ensure appropriate labeling includes warnings regarding the use of non-invasive bone growth stimulators with patients who have implanted devices, specifying any necessary separation distances.
Manufacturers must provide robust clinical data to demonstrate that non-invasive bone growth stimulators perform as intended under anticipated conditions of use.