The FDA has issued a final order requiring premarket approval applications for transilluminators for breast evaluation and sorbent hemoperfusion systems for treating hepatic coma and metabolic disturbances. The order also reclassifies SHS systems from Class III to Class II when used to treat poisoning or drug overdose.
The agency left preamendment breast transilluminators in Class III, siding with an April 2012 advisory panel meeting that deemed general and special controls insufficient to assure the safety and effectiveness of the devices for diagnosing cancer and other conditions. Today’s notice notes that transilluminators have widely fallen into disuse.
Last July, the panel concluded that SHS for hepatic coma and metabolic disturbances also remain in Class III, citing “insufficient information to establish special controls.”
The panel also supported the FDA’s conclusions that SHS for poisoning and drug overdoses could be adequately regulated in Class II, with general and specific controls.
Manufacturers of transilluminators and SHS for hepatic coma and metabolic disturbances now have 90 days to submit a PMA or product development protocol or have their products rendered adulterated under section 501(f) of the FD&C Act, the notice says.
Devicemakers submitting a 510(k) application for SHS for poisoning or drug overdoses will need to either comply with mitigation measures set forth in the special controls guideline or identify alternative mitigation methods that prove safety and effectiveness. A list of the necessary controls is in the notice.
Read the Federal Register notice at www.fdanews.com/ext/resources/files/01/01-17-14-PMA.pdf. — Lena Freund
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