| ASTM F703-18 Standard Specification for Implantable Breast Prostheses |
| Recognition Number | General Plastic Surgery/General Hospital |
| Recognition Date | 2018-09-17 |
| Recognition List | 050 |
| Recognition Number | 6-409 |
| Extent | Complete standard |
| Standards Orgs | ASTM ASTM International http://www.astm.org/ |
| STG | General Plastic Surgery/General Hospital |
| FDA Tech | George Ngatha FDA/OMPT/CDRH/OC/DMQ/ASDB/ 301-796-6444 george.ngatha@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.
1.1 This specification covers the requirements for silicone gel-filled and saline-inflatable silicone gel-filled implantable breast prostheses intended for use in surgical reconstruction, augmentation, or replacement of the breast.
1.2 Limitations-This specification does not cover custom fabricated implantable breast prostheses.
1.3 Single-use saline-inflatable, smooth, and textured silicone shell implantable breast prostheses are addressed in Specification F2051.
1.4 The values stated in SI units are to be regarded as the standard. The inch-pound units given in parentheses are for information only.
| Regulation Number | Device Name | Device Class | Product Code |
| §878.3540 | Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled | Class 3 | FTR |
| §878.3530 | Prosthesis, Breast, Inflatable, Internal, Saline | Class 3 | FWM |
| There is no relevant guidance developed at this time. |