| ASTM D6976-13R18 Standard Specification for Rubber Contraceptives - Vaginal Diaphragms |
| Recognition Date | 2014-01-30 |
| Recognition List | 034 |
| Recognition Number | 9-85 |
| Extent | Complete standard |
| Standards Orgs | ASTM ASTM International http://www.astm.org/ |
| STG | ObGyn/Gastroenterology/Urology |
| FDA Tech | Sharon Andrews FDA/OMPT/CDRH/ODE/DRGUD/OGDB/ 301-796-6529 sharon.andrews@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
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.
| Regulation Number | Device Name | Device Class | Product Code |
| §884.5350 | Diaphragm, Contraceptive (And Accessories) | Class 2 | HDW |
| Guidance for Industry: User Labeling for Devices that Contain Natural Rubber (21 CFR 801.437); Small Entity Compliance Guide, Issued April 2003. |