Recognized standard
F703-18
FDA recognition 6-409 · ASTM · General Plastic Surgery/General Hospital
Key facts
| Recognition number | 6-409 |
|---|---|
| Designation | F703-18 |
| Title | Standard Specification for Implantable Breast Prostheses |
| Standards developer | ASTM International |
| Specialty area | General Plastic Surgery/General Hospital |
| Date of entry | Sep 17, 2018 |
| Device classes | Class 3 |
| Scope (excerpt) | 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… |
At a glance
- 1–9 Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: