FOOD AND DRUG ADMINISTRATION ISSUES RULE: PHYSICAL MEDICINE DEVICES; RECLASSIFICATION OF NON-INVASIVE BONE GROWTH STIMULATORS

WASHINGTON, April 16 -- Food and Drug Administration has issued a rule called: Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators.

The rule was published in the Federal Register on April 16 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA) is issuing a final order to reclassify non-invasive bone growth stimulators (product codes LOF and LPQ), postamendments class III devices, into class II, subject to premarket notification. FDA is codifying the reclassification of these devices under the new classification regulation, "non-invasive bone growth stimulator." FDA is also establishing the special controls necessary to pr...