FDA BRIEF: Week of April 17, 2017

FDA approved


renflexis.JPG

RENFLEXIS (infliximab-abda) intravenous infusion

Samsung Bioepis Co., Incheon, Republic of Korea

INDICATIONS: Multiple

  • Crohn’s Disease
  • Pediatric Crohn’s Disease
  • Ulcerative Colitis
  • Rheumatoid Arthritis
  • Ankylosing Spondylitis
  • Psoriatic Arthritis
  • Plaque Psoriasis

REG PATHWAY: Biosimilar to REMICADE (infliximab)

  • Biological product approved based on showing high similarity to  reference product (infliximab)
  • No clinically meaningful differences in safety and effectiveness from reference
  • Only minor differences in clinically inactive components

LABEL


class


Pathology

philips

PHILIPS INTELLISITE PATHOLOGY SOLUTION (PIPS)

Philips Medical Systems, Nederland B.V.

INDICATION FOR USE:

Automated digital slide creation, viewing, and management system. The PIPS is intended for in vitro diagnostic use as an aid to the pathologist to review and interpret digital images of surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue.

The PIPS is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens.

The PIPS comprises the Image Management System (IMS), the Ultra Fast Scanner (UFS) and Display. The PIPS is for creation and viewing of digital images of scanned glass slides that would otherwise be appropriate for manual visualization by conventional light microscopy.

It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images obtained using PIPS.

ADDRESSING UNMET NEED:

  • First authorized whole slide imaging system
  • Enables pathologists to read tissue slides digitally in order to make diagnoses
  • Streamlined slide storage and retrieval system

REG PATHWAY: De Novo request

  • Regulation Number: 21 CFR 864.3700
  • Regulation Name: Whole Slide Imaging System
  • Regulatory Classification: Class II
  • Product Code: PSY

GENERIC DEVICE TYPE: Whole Slide Imaging System

Automated digital slide creation, viewing, and management system intended as an aid to the pathologist to review and interpret digital images of surgical pathology slides. The system generates digital images that would otherwise be appropriate for manual visualization by conventional light microscopy.

RISKS & MITIGATIONS:

  • Inaccurate or missing results leading to, for example, incorrect diagnosis: General and Special Controls
  • Delayed results: General and Special Controls

CLASSIFICATION ORDER


Device
electroCore

GAMMACORE Non-invasive Vagus Nerve Stimulator

electroCore, LLC, Basking Ridge, NJ, USA

INDICATION FOR USE:  To provide noninvasive vagus nerve stimulation (nVNS) on the side of the neck. The gammaCore device is indicated for the acute treatment of pain associated with episodic cluster headache in adult patients.

REG. PATHWAY: De Novo Request

  • Regulation Number: 21 CFR 882.8592
  • Regulation Name: External vagal nerve stimulator for headache
  • Regulatory Classification: Class II
  • Product Code: PKR

GENERIC DEVICE TYPE: External vagal nerve stimulator for headache

Prescription device used to apply an electrical current to a patient’s vagus nerve through electrodes placed on the skin for the treatment of headache.

RISKS & MITIGATIONS:

  • Adverse tissue reaction resulting from patient contacting components:  Biocompatibility evaluation, Labeling
  • Electrical shock injury from device failure: Electrical safety, thermal, and mechanical testing, Software verification, validation, and hazard analysis, Labeling
  • Stimulation side effects such as Seizure, Cardiac side effects, Worsening of headache: Labeling
  • Ineffective therapeutic response due to device failure: Non-clinical performance testing, Software verification, validation and hazard analysis, Labeling
  • User error: Labeling

CLASSIFICATION ORDER


 

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