FDA proposes down-classifying bone grown stimulators
The US Food and Drug Administration (FDA) on Friday proposed to reclassify non-invasive bone growth stimulators under two product codes from class III to class II, allowing the devices to be marketed with 510(k) clearance rather than requiring premarket approval (PMA).Non-invasive bone growth stimulators are postamendments devices that were automatically classified as class III devices in 1979 with the PMA for the Bio Osteogen System 204. FDA has since approved five additional PMAs for non-invasive bone growth stimulators.
While FDA is proposing to reclassify the devices on its own initiative, it had previously declined a request made in 2005 by RS Medical Corporation to reclassify certain non-invasive bone growth stimulators to class II. Both FDA and its Orthopaedic and Rehabilitation Devices Panel felt the devices should remain in class III, citing insufficient information in the petition and “concerns about the petitioner’s proposed special controls to control the risk of inconsistent or ineffective treatment.” In 2007, RS Medical requested the petition be withdrawn, which FDA granted.
However, FDA later identified non-invasive bone growth stimulators as a candidate for reclassification as part of a retrospective review of PMAs approved prior to 2010 as part of its 2014-2015 strategic priority to “strike the right balance between premarket and postmarket data collection.” (RELATED: FDA looks to fine-tune the balance between premarket device data and postmarket requirements, Regulatory Focus 8 August 2016).
FDA notes that the proposed order would only apply to non-invasive bone grown stimulators under product codes LOF and LPQ and does not apply to invasive devices under product code LOE. FDA notes that invasive bone growth stimulators carry added risks over non-invasive devices and that a previous PMA retrospective review determined that those devices should continue to be regulated as class III devices.
FDA says it now believes that, “There is sufficient information to establish special controls, which in addition to general controls, with provide reasonable assurance of the safety and effectiveness of the device,” adding that the order will apply to all the devices’ approved indications.
Based on its review of the devices, FDA says it has identified seven risks to health posed by non-invasive bone growth stimulators. To address those risks, the agency is proposing special controls for the devices, including the collection of clinical performance data; non-clinical performance testing; software verification, validation and hazard analysis; electrical safety testing; electromagnetic compatibility testing; and labeling measures.