| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
052
|
Date of Entry 07/15/2019
|
|
FR Recognition Number
|
6-422
|
| Standard | |
AAMI TIR38:2019
Medical device safety assurance case guidance |
|
Scope/Abstract| 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
|
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
|
| Standards Development Organization
|
FDA Specialty Task Group (STG)
| General Plastic Surgery/General Hospital |
|
| *These are provided as examples and others may be applicable. |
