| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
046
|
Date of Entry 12/23/2016
|
|
FR Recognition Number
|
13-85
|
| Standard | |
CLSI AUTO11-A2
Information Technology Security of In Vitro Diagnostic Instruments and Software Systems; Approved Standard - Second Edition |
|
Scope/Abstract| This document provides a framework for communication of information technology security issues between the in vitro diagnostic system vendor and the health care organization. |
|
| Extent of Recognition
|
Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §862.2100 |
Calculator/Data Processing Module, For Clinical Use
|
Class 1
|
JQP
|
| Automated instrumentation under:
Part 862 Clinical Chemistry and Clinical Toxicology Devices
Part 864 Hematology and Pathology Devices
Part 866 Immunology and Microbiology Devices |
|
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry - Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software, issued on January 14, 2005.
Content of Premarket Submissions for Management of Cybersecurity in Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued on October 2, 2014.
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 Groups (STG)
| Software/Informatics (primary) |
| InVitro Diagnostics |
|
| *These are provided as examples and others may be applicable. |
