ISO 29943-2 First edition 2017-07 Medical Standard

Condoms -- Guidance On Clinical Studies -- Part 2: Female Condoms, Clinical Function Studies Based On Self-reports.

29943-2 First edition 2017-07

Standard Organization: ISO

ISO 29943-2 First edition 2017-07
Condoms -- Guidance on clinical studies -- Part 2: Female condoms, clinical function studies based on self-reports.

Recognition Number

ObGyn/Gastroenterology/Urology

Recognition Date

2018-06-07

Recognition List

049

Recognition Number

9-116

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 29943-2:2017 is intended to help in the design, execution, analysis, and interpretation of clinical function studies conducted in accordance with the requirements of ISO 25841 for female condoms. These clinical studies compare the performance of a new female condom to an established female condom during vaginal intercourse (not anal intercourse). In particular, these studies are designed to assess acute failure events during use. ISO 29943-2:2017 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

§884.5340

Single-Use Internal Condom

Class 2

MBU

FDA Guidance:

Recognized Consensus Standards