Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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060
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Date of Entry 05/29/2023
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FR Recognition Number
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9-145
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Standard | |
ASTM D7661-18 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms |
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Scope/Abstract1.1 This test method covers procedures used to detect a shift in physical properties of natural rubber latex (NRL) condoms after immersion in a personal lubricant. "Personal lubricants" are lubricants such as liquids or gels that are applied by the consumer at the time of condom use. 1.2 This test method does not attempt to address compatibility of lubricants applied to a condom at the time of manufacture ("manufacturer lubricants"). It shall be the responsibility of the condom manufacturer to verify the long-term stability (shelf life) of any manufacturer lubricant that is packaged within the individual condom wrapper. Other regulatory requirements may apply.
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Extent of Recognition
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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 |
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Transition Period
FDA recognition of ASTM D7661-10 (Reapproved 2017) [Rec# 9-67] will be superseded by recognition of ASTM D7661-18 [Rec# 9-145]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 9-67] until July 6, 2025. After this transition period, declarations of conformity to [Rec# 9-67] will not be accepted. |
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Public Law, CFR Citation(s) and Procode(s)*
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Relevant FDA Guidance and/or Supportive Publications*
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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FDA Technical Contact
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Standards Development Organization
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FDA Specialty Task Group (STG)
ObGyn/Gastroenterology/Urology |
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*These are provided as examples and others may be applicable. |