# 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
> **Food and Drug Administration** · Final order. · Published 2014-01-17 · Effective 2014-01-17 · 79 FR 3088
## Document
- **Document number:** 2014-00873
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 79 FR 3088
- **CFR reference:** 21 CFR 876
- **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).

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2014/01/17/2014-00873/effective-date-of-requirement-for-premarket-approval-for-transilluminator-for-breast-evaluation-and)
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