On Friday, June 2, the FDA's Orthopedic and Rehabilitation Devices Panel met to discuss the RS Medical petition to reclassify noninvasive bone growth stimulators from Class III to Class II. In a 4-2 vote, the panel recommended leaving the bone stimulators Class III. Presumably, the FDA will follow the recommendation when it makes its final decision.
The decision was not an easy one to make, with the panel initially voting to reclassify and then revoting and reversing its recommendation. The reversal was based upon concerns raised around clinical data and the difficulty the FDA would have ensuring Class II bone growth stimulators were equivalent to predicates.
The result of this recommendation most benefits the opposing companies, Biomet, DJO Inc. and Orthofix, which have products in this market. A downclassification would not only have meant that RS Medical, a privately held electrostimulation company, would have easier entry into the market, but other competitors as well.
Remaining Class III also means the devices will remain exempt from Medicare's durable medical equipment bidding program, which protects their pricing.
Overall, it was a victory for the big players.
