Submit either electronic or written comments on the proposed order by October 16, 2020. If finalized, this order will reclassify these devices from class III (premarket approval) to class II (special controls) and reduce the regulatory burdens associated with these devices, as these devices will no longer be required to submit a premarket approval application (PMA), but are subject to premarket notification (510(k)) requirements and general and special controls. FDA is proposing this reclassification on its own initiative. FDA is also proposing a new device classification with the name “non-invasive bone growth stimulators” along with the proposed special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness of these devices. The Food and Drug Administration (FDA) is proposing to reclassify non-invasive bone growth stimulators, postamendments class III devices (product codes LOF and LPQ), into class II (special controls), subject to premarket notification. Proposed amendment proposed order request for comments. Provide legal notice to the public or judicial notice to the courts.įood and Drug Administration, Health and Human Services (HHS). Rendition of the daily Federal Register on does not Until the ACFR grants it official status, the XML Legal research should verify their results against an official edition of
#Exogen bone stimulator pdf#
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