| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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064
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Date of Entry 05/26/2025
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|
FR Recognition Number
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13-143
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| Standard | |
AAMI TIR45:2023
Guidance on the use of AGILE practices in the development of medical device software |
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Scope/Abstract| Over the past several years, AGILE software development has become an accepted method for developing software products. There have been questions from both manufacturers and regulators as to whether (or which) AGILE practices are appropriate for developing medical device software. Enough medical device manufacturers have implemented AGILE practices in their software development so that answers to these questions can be documented. Having clear guidance of which practices have been found to be appropriate will be very useful for all developers of medical device software. This TIR will provide recommendations for complying with international standards and U.S. Food and Drug Administration (FDA) guidance documents when using AGILE practices to develop medical device software. |
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| Extent of Recognition
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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. |
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Transition Period
| FDA recognition of AAMI TIR 45:2012 [Rec# 13-36] will be superseded by recognition of AAMI TIR45:2023 [Rec# 13-143]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 13-36] until July 2, 2028. After this transition period, declarations of conformity to [Rec# 13-36] will not be accepted. |
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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §876.1500 |
Mobile / Tablet Software Application To Control Settings Of Surgical And Endoscopic Camera
|
Class 2
|
QGY
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| 21 CFR 820.30 Design Controls |
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Relevant FDA Guidance and/or Supportive Publications*
Content of Premarket Submissions for Device Software Functions Guidance for Industry and Food and Drug Administration Staff, June 2023.
Off-the-Shelf Software Use in Medical Devices, Guidance for Industry and Food and Drug Administration Staff August 2023.
General Principles of Software Validation; Guidance for Industry and FDA Staff, January 2002.
Computer Software Assurance for Production and Quality System Software, Draft Guidance for Industry and Food and Drug Administration Staff September 2022.
ISO 13485:2016, Quality management systems - Requirements for regulatory purposes.
ANSI AAMI IEC 62304:2006/A1:2016, Medical device software - Software life cycle processes [Including Amendment 1 (2016)].
ANSI AAMI ISO 14971: 2019 Medical devices - Applications of risk management to medical devices.
IMDRF Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations 18 September 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. |
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| FDA Technical Contacts
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| Standards Development Organization
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| FDA Specialty Task Group (STG)
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| *These are provided as examples and others may be applicable. |
