Update: Court Dismisses Lawsuit Challenging FDA Decision in Device Reclassification Petition

By Susan J. Matthees –

Last year we reported that FDA had moved to dismiss a lawsuit alleging that FDA had improperly denied HiFi DNA Tech, LLC’s (“HiFi’s”) petition for reclassification of an HPV nested DNA polymerase chain reaction detection device from Class III to Class II.  The U.S. District Court for the District of Connecticut recently granted FDA’s motion to dismiss the case. 

HiFi had submitted a 510(k) submission for its device, but FDA responded with a letter stating that the device would be classified as a Class III device and thus would require Premarket Approval from FDA.  HiFi responded to this letter with a request that FDA reclassify the device from Class III to Class II, which FDA denied.  HiFi filed a complaint in district court challenging FDA’s action.  

In dismissing the case, the court concluded “that the FDA’s denial of HiFi’s reclassification petition is not ‘arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.’”  The court found that FDA gave HiFi’s petition a thorough review and responded to each of HiFi’s arguments.  Further, because FDA was interpreting its own statutes and regulations when it made its decision, the court was “especially deferential” of the agency’s decision.