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 Devices for the Treatment of Poisoning and Drug Overdose
fda-device · Food and Drug Administration · Rule · Published 2014-01-17 · Effective 2014-01-17 · 79 FR 3088
Document
Document number
2014-00873
Federal Register citation
79 FR 3088
CFR reference
21 CFR 876
Type
Rule
Action
Final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2014-01-17
Effective date
2014-01-17
HHS docket
Docket No. FDA-2013-N-0195
Abstract
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).