Effective date of requirement for premarket approval for transilluminator for breast evaluation and sorbent hemoperfusion system (SHS) devices for the treatment of hepatic coma and metabolic disturbances; reclassification of SHS and devices for the treatment of poisoning and drug overdose. Final order.
The Food and Drug Administration (FDA) is issuing a final order to require the filing of a premarket approval application (PMA) for the transilluminator for breast evaluation and sorbent hemoperfusion system (SHS) devices for the treatment of hepatic coma and metabolic disturbances and to reclassify SHS devices for the treatment of poisoning and drug overdose, a preamendments class III device, into class II (special controls).
D018795:Device Approval / Q000331:legislation & jurisprudence*; D062787:Drug Overdose / Q000628:therapy; D004869:Equipment Safety / Q000145:classification / Q000295:instrumentation; D006464:Hemoperfusion / Q000145:classification* / Q000295:instrumentation; D006501:Hepatic Encephalopathy / Q000628:therapy; D006801:Humans; D008659:Metabolic Diseases / Q000628:therapy; D011041:Poisoning / Q000628:therapy; D014172:Transillumination / Q000145:classification* / Q000295:instrumentation; D014481:United States