| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
031
|
Date of Entry 08/06/2013
|
|
FR Recognition Number
|
7-243
|
| Standard | |
CLSI M51-A (Replaces M51-P)
Method for Antifungal Disk Diffusion Susceptibility Testing of Nondermatophyte Filamentous Fungi; Approved Guideline |
|
Scope/Abstract| This document describes the guidelines for antifungal susceptibility testing by the disk diffusion method of nondermatophyte filamentous fungi (moulds) that cause invasive disease. |
|
Extent of Recognition
| Partial recognition. The following part(s) of the standard is (are) not recognized: |
| Section 8.1 Zone Diameter Epidemiological Cutoff Values |
|
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.
Section 8.1 is in conflict with FDA approved drug labeling, see FDA- Antifungal Susceptibility Test Interpretive Criteria listed below. |
|
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*
Antifungal Susceptibility Test Interpretive Criteria website: https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm410971.htm
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
|
| Standards Development Organization
|
| FDA Specialty Task Group (STG)
|
| *These are provided as examples and others may be applicable. |
