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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 034 Date of Entry 01/30/2014 
FR Recognition Number 9-85
Standard
ASTM  D6976-13R18
Standard Specification for Rubber Contraceptives - Vaginal Diaphragms
Scope/Abstract
This specification covers requirements for contraceptive vaginal diaphragms, hereafter called diaphragms. Vaginal barrier devices known as cervical caps, vaginal sponges and female condoms are not included in this specification.

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
§884.5350 Diaphragm, Contraceptive (And Accessories) Class 2 HDW
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry: User Labeling for Devices that Contain Natural Rubber (21 CFR 801.437); Small Entity Compliance Guide, Issued April 2003.

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
 Sharon Andrews
  FDA/OC/CDRH/OPEQ/OHTIII/DHTIIIB/
  301-796-6529
  sharon.andrews@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
ObGyn/Gastroenterology/Urology
*These are provided as examples and others may be applicable.
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