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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 056 Date of Entry 06/07/2021 
FR Recognition Number 9-132
Standard
ASTM F623-19
Standard Performance Specification for Foley Catheter
Scope/Abstract
This performance specification establishes performance requirements for the short-term utilization of a single-use, balloon-retention catheter, French s 12 through 26 inclusive, used by the medical professions for providing a means of bladder drainage by means of the urethra. The product is manufactured in various s and materials such as latex, silicone, rubber, and various polymers (as well as combinations of these) and is provided nonsterile for sterilization and sterile for single use only. Catheters whose surface has been chemically treated to effect biocompatibility or microbial properties may be tested to this specification.
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.
Transition Period
FDA recognition of ASTM F623-99 (Reapproved 2013) [Rec# 9-44] will be superseded by recognition of ASTM F623-19 [Rec# 9-132]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 9-44] until July 10, 2022. After this transition period, declarations of conformity to [Rec# 9-44] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§876.5130 Accessories, Catheter, G-U Class 2 KNY
§876.5130 Adaptor, Ureteral Catheter Class 1 EYI
§876.5130 Catheter Care Tray Class 2 OHR
§876.5130 Catheter, Coude Class 2 EZC
§876.5130 Catheter, Double Lumen Female Urethrographic Class 2 FGH
§876.5130 Catheter, Retention Type, Balloon Class 2 EZL
§876.5130 Catheter, Straight Class 2 EZD
§876.5130 Catheter, Upper Urinary Tract Class 2 EYC
§876.5130 Catheter, Ureteral Disposable (X-Ray) Class 2 FGF
§876.5130 Catheter, Ureteral, Gastro-Urology Class 2 EYB
§876.5130 Catheter, Ureteral, General & Plastic Surgery Class 2 GBL
§876.5130 Catheter, Urethral Class 2 GBM
§876.5130 Catheter, Urethrographic, Male Class 2 FGI
§876.5130 Catheter, Urological Class 2 KOD
§876.5130 Catheter, Urological (Antimicrobial) And Accessories Class 2 MJC
§876.5130 Connector, Ureteral Catheter Class 1 EYK
§876.5130 Holder, Ureteral Catheter Class 1 EYJ
§876.5130 Kit, Catheter, External, Male (Excludes Hiv Testing) Class 2 NWQ
§876.5130 Kit, Catheter, Foley (Excludes Hiv Testing) Class 2 NWR
§876.5130 Kit, Catheter, Urinary (Exludes Hiv Testing) Class 2 NWO
§876.5130 Stylet For Catheter, Gastro-Urology Class 1 EZB
§876.5130 Stylet, Ureteral Class 1 EYA
§876.5130 Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) Class 2 FCM
Relevant FDA Guidance and/or Supportive Publications*
1. Guidance for Content of Premarket Notifications for Conventional and Antimicrobial Foley Catheters, Issued September 1994.
2. Conventional Foley Catheters - Performance Criteria for Safety and Performance Based Pathway, Guidance for Industry and Food and Drug Administration Staff, Issued August 2020.
FDA Technical Contact
 Jessica Nguyen
  FDA/OC/CDRH/OPEQ/OHTIII/DHTIIIA
  301-796-6277
  Jessica.Nguyen@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
ObGyn/Gastroenterology/Urology
*These are provided as examples and others may be applicable.
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