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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 034 Date of Entry 01/30/2014 
FR Recognition Number 5-84
AAMI  TIR 49:2013/(R)2020
Technical Information Report Design of training and instructional materials for medical devices used in non-clinical environments
The purpose of this technical information report (TIR) is to provide a relevant source of information, design criteria, and guidelines for the instructional and training materials and processes intended to accompany medical devices used in a non-clinical environment, which for the purpose of this document, is defined as an environment other than a facility where a health professional is continually present whenever a patient is present.
However, much of the information presented in this document can be applied, as well, to the design of instructions and training for the use of medical devices that will be used within clinical environments or in both clinical and nonclinical environments. The information in this document also applies to training and instructions for the use of combination products (e.g., transdermal drug delivery patches), which manufacturers sometimes do not consider to
be medical devices.
These guidelines are meant to supplement Annex D of ANSI/AAMI/IEC 62366:2007, ANSI/AAMI HE75:2009, and the numerous references available on the topic of human factor engineering, with a focus on the training and instructional materials that accompany medical devices used outside of clinical environments
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.
Relevant FDA Guidance and/or Supportive Publications*
CDRH Guidance on Medical Device Patient Labeling; Final Guidance for Industry and FDA Reviewers, April 19, 2001

Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management, July 18, 2000

CDRH Guidance on Assessing the Safety and Effectiveness of Home-Use In Vitro Diagnostic Devices (IVDs): Draft Points to Consider Regarding Labeling and Premarket Submissions, October 1988

Mobile Medical Applications, Guidance for Industry and Food and Drug Administration Staff, September 25, 2013

Design Considerations for Devices Intended for Home Use, Draft Guidance for Industry and Food and Drug Administration Staff, December, 2012

Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and Food and Drug Administration Staff, Document Issued on: August 13, 2013

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
 Joann Brumbaugh
 Tosia Hazlett
Standards Development Organization
AAMI Association for the Advancement of Medical Instrumentation http://www.aami.org
FDA Specialty Task Group (STG)
General I (QS/RM)
*These are provided as examples and others may be applicable.