| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
050
|
Date of Entry 09/17/2018
|
|
FR Recognition Number
|
9-117
|
| Standard | |
ISO 16038 Second edition 2017-11
Male condoms - Guidance on the use of ISO 4074 and ISO 23409 in the quality management of condoms |
|
Scope/Abstract| This document provides guidance on using ISO 4074 and ISO 23409 and addresses quality issues to be considered during the development, manufacture, quality verification and procurement of condoms. It encompasses the aspects of quality management systems in the design, manufacture and delivery of condoms with an emphasis on performance, safety and reliability.Male condoms are either made from essentially natural rubber latex, in which case the requirements of ISO 4074 are applicable, or from synthetic materials and/or blends of synthetic materials and natural rubber latex, in which case the requirements of ISO 23409 are applicable. This document outlines the aspects applicable to both types of condoms with specific clarifications where appropriate. |
|
| 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 |
| §884.5300 |
Condom
|
Class 2
|
HIS
|
| §884.5310 |
Condom With Nonoxynol-9
|
Class 2
|
LTZ
|
|
Relevant FDA Guidance and/or Supportive Publications*
Latex Condoms for Men: Information for 510(k) Premarket Notifications: Use of Consensus Standards for Abbreviated Submissions, Issued July 1998.
Guidance for Industry: Designation of Special Controls for Male Condoms Made of Natural Rubber Latex (21 CFR 884.5300); Small Entity Compliance Guide, Issued January 2009.
Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300, Issued December 2008.
Guidance for Industry and FDA Staff: Surveillance and Detention without Physical Examination of Condoms, Issued July 2008.
Testing Guidance for Male Condoms Made from New Material (Non-Latex), Issued June 1995.
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)
| ObGyn/Gastroenterology/Urology |
|
| *These are provided as examples and others may be applicable. |
