FDA established a new device classification for non-invasive bone growth stimulators.
The agency added § 890.5870 to 21 CFR Part 890, creating a Class II regulatory pathway for devices that use electrical, magnetic, or ultrasonic fields to promote bone healing.
These prescription devices are intended for external use to support osteogenesis as adjunct therapy for fracture fixation and spinal fusion, or as treatment for nonunions and failed fusions.
Here is what manufacturers need to comply with:
1 / Clinical data requirements include imaging evidence showing fusion at treatment sites and device performance documentation.
2 / Non-clinical testing covers thermal safety validation, signal characteristics within physiologic limits, and device reliability testing.
3 / Biocompatibility testing is required for all patient-contacting components.
4 / Electrical safety and electromagnetic compatibility validation must be completed.
5 / Software verification, validation, and hazard analysis are mandatory for devices with software components.
6 / Labeling comprehension testing ensures patients can operate the device using instructions alone.
7 / Extensive labeling requirements include warnings for compromised skin, patients with implanted devices, clinical data summaries, usage instructions, and specific warnings about burns, electrical shock, and skin irritation.
This classification provides manufacturers with a clear regulatory pathway for bone growth stimulation devices that previously required individual determinations.
Source: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-890/subpart-F