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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 049 Date of Entry 06/07/2018 
FR Recognition Number 9-115
Standard
ISO 29943-1 First edition 2017-07.
Condoms -- Guidance on clinical studies -- Part 1: Male condoms, clinical function studies based on self-reports
Scope/Abstract
ISO 29943-1:2017 is intended to help in the design, execution, analysis and interpretation of clinical function studies conducted in accordance with the requirements of ISO 23409 for male synthetic condoms. These clinical studies compare the performance of a new male condom to an established male condom during vaginal intercourse (not anal intercourse). In particular, these studies are designed to assess acute failure events during use (i.e. clinical slippage and clinical breakage). ISO 29943-1:2017 also provides direction on the analysis of data when the study is completed, as well as interpretation of these results by manufacturers and regulatory bodies. Certain clinical trial elements are not addressed in this document, including compensation, confidentiality of individuals and their records, use of local ethics committees, etc. These and many other clinical trial design issues are covered in greater detail in ISO 14155.
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
§884.5300 Condom Class 2 HIS
§884.5300 Condom Class 2 HIS
§884.5300 Condom, Synthetic Class 2 MOL
§884.5300 Barrier, Std, Oral Sex Class 2 MSC
§884.5300 Lubricant, Personal Class 2 NUC
§884.5300 Seminal Fluid Collection Kit Class 2 OKW
§884.5300 Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible Class 2 PEB
§884.5300 Personal Lubricant Ring Class 2 QPD
Relevant FDA Guidance and/or Supportive Publications*
Testing guidance for Male Condoms Made from New Material (Non-Latex), Issued June 1995.
FDA Technical Contact
 Sharon Andrews
  FDA/OC/CDRH/OPEQ/OHTIII/DHTIIIB/
  301-796-6529
  sharon.andrews@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
ObGyn/Gastroenterology/Urology
*These are provided as examples and others may be applicable.
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