ISO 29943-1 First edition 2017-07.

Condoms -- Guidance On Clinical Studies -- Part 1: Male Condoms, Clinical Function Studies Based On Self-reports

29943-1 First edition 2017-07.

Standard Organization: ISO

ISO 29943-1 First edition 2017-07.
Condoms -- Guidance on clinical studies -- Part 1: Male condoms, clinical function studies based on self-reports

Recognition Number	ObGyn/Gastroenterology/Urology
Recognition Date	2018-06-07
Recognition List	049
Recognition Number	9-115
Extent	Complete standard
Standards Orgs	ISO International Organization for Standardization https://www.iso.org/
STG	ObGyn/Gastroenterology/Urology
FDA Tech	Sharon Andrews FDA/OMPT/CDRH/ODE/DRGUD/OGDB/ 301-796-6529 sharon.andrews@fda.hhs.gov

Rationale:

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Scope:

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.

Code of Federal Regulations:

Regulation Number	Device Name	Device Class	Product Code
§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	Condom	Class 2	HIS

FDA Guidance:

Testing guidance for Male Condoms Made from New Material (Non-Latex), Issued June 1995.