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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 052 Date of Entry 07/15/2019 
FR Recognition Number 6-422
AAMI  TIR38:2019
Medical device safety assurance case guidance
This TIR is a safety case development reference for medical device design. The TIR is intended to provide a framework within which experience, insight, and judgment are applied systematically to assure and document the safety of a medical device's design.
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.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§880.5725 Pump, Infusion Class 2 FRN
§880.5725 Pump, Infusion, Insulin Class 2 LZG
§880.5725 Pump, Infusion, Enteral Class 2 LZH
§880.5725 Pump, Infusion, Pca Class 2 MEA
§880.5725 Pump, Infusion, Elastomeric Class 2 MEB
§880.5725 Accessories, Pump, Infusion Class 2 MRZ
§880.5725 Pump, Infusion, Insulin Bolus Class 2 OPP
§880.5725 Infusion Safety Management Software Class 2 PHC
§880.5730 Alternate controller enabled infusion pump.
N/A Pump, Infusion, Implanted, Programmable Class 3 LKK
Relevant FDA Guidance and/or Supportive Publications*
Infusion Pumps Total Product Life Cycle: Guidance for Industry and FDA Staff, Issued December 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 Contact
 Jake Lindstrom
Standards Development Organization
AAMI Association for the Advancement of Medical Instrumentation http://www.aami.org
FDA Specialty Task Group (STG)
General Plastic Surgery/General Hospital
*These are provided as examples and others may be applicable.