Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

020

Date of Entry 09/09/2008 

FR Recognition Number

13-14

Standard

CLSI  POCT1-A2
Point-of-Care Connectivity

Scope/Abstract

This document provides the framework for engineers to design devices, work stations, and interfaces that allow multiple types and brands of point-of-care devices to communicate bidirectionally with access points, data managers, and laboratory information systems from a variety of vendors.

Extent of Recognition

Complete standard

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

Relevant FDA Guidance and/or Supportive Publications*

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

Yan Zhang   CDRH/OPEQ/OHTVII/DMGP/MGB   301-837-7386   yan.zhang1@fda.hhs.gov

Thomas Miller   CDRH/OPEQ/OHTVII/DCTD/CB   240-402-8938   Thomas.Miller@fda.hhs.gov

Standards Development Organization

CLSI Clinical Laboratory Standards Institute https://clsi.org/

FDA Specialty Task Group (STG)

Software/Informatics

*These are provided as examples and others may be applicable.