Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

050

Date of Entry 09/17/2018

FR Recognition Number

7-278

Standard

CLSI M27 4th Edition
Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts

Scope/Abstract

This standard covers antifungal agent selection and preparation, test procedure implementation and interpretation, and quality control requirements for susceptibility testing of yeasts that cause invasive fungal infections.

Extent of Recognition

Complete standard

Rationale for Recognition

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Public Law, CFR Citation(s) and Procode(s)*

Regulation Number	Device Name	Device Class	Product Code
§866.1620	Susceptibility Test Discs, Antimicrobial	Class 2	JTN
§866.1620	Discs, Elution	Class 2	LTX
§866.1640	Susceptibility Test Plate, Antifungal	Class 2	NGZ
§866.1700	Culture Media, Antifungal, Susceptibility Test	Class 2	MJE

Relevant FDA Guidance and/or Supportive Publications*

Systemic Antibacterial and Antifungal Drugs: Susceptibility Test Interpretive Criteria Labeling for NDAs and ANDAs Guidance for Industry, Issued December 2017.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.

FDA Technical Contacts

Ribhi Shawar

FDA/OC/CDRH/OPEQ/OIDRH/DMD/BAC1/

301-796-6698

ribhi.shawar@fda.hhs.gov

Jeffrey Brocious

FDA/OC/CDRH/OPEQ/OIDRH/DMD/BAC2/

240-402-3797

jeffrey.brocious@fda.hhs.gov

Standards Development Organization

CLSI

Clinical Laboratory Standards Institute