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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 030 Date of Entry 01/15/2013 
FR Recognition Number 13-33
Standard
AAMI  TIR 36:2007
Validation of software for regulated processes
Scope/Abstract
Applies to any software used to automate device design, testing, component acceptance, manufacturing, labeling, packaging, distribution, and complaint handling or to automate any other aspect of the quality system as defined by the Quality System Regulation (21 CFR 820). In addition, it applies to software used to create, modify, and maintain electronic records and to manage electronic signatures that are subject to the validation requirements (21 CFR 11). This TIR can also be broadly applied wherever software automates processes regulated by the FDA. This TIR applies to software used in the production of a device and to software used in implementation of the device manufacturer's quality system. It does not apply to software used as a component, part, or accessory of a medical device or software that is itself a medical device.
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*
Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - Guidance for Industry and FDA Staff, May 2005

Guidance for Off-the-Shelf Software Use in Medical Devices, September 1999

General Principles of Software Validation; Final Guidance for Industry and FDA Staff, January 2002

Guidance for Industry - Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software, January 2005

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 Contact
 Lisa Simone
  FDA/OC/CDRH/OSPTI/DAHRSSP/
  301-796-2591
  Lisa.Simone@fda.hhs.gov
Standards Development Organization
AAMI Association for the Advancement of Medical Instrumentation http://www.aami.org
FDA Specialty Task Group (STG)
Software/Informatics
*These are provided as examples and others may be applicable.
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