Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
|
050
|
Date of Entry 09/17/2018
|
FR Recognition Number
|
6-409
|
Standard | |
ASTM F703-18 Standard Specification for Implantable Breast Prostheses |
|
Scope/Abstract1.1 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. |
|
Extent of Recognition
|
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 |
§878.3530 |
Prosthesis, Breast, Inflatable, Internal, Saline
|
Class 3
|
FWM
|
§878.3540 |
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
|
Class 3
|
FTR
|
|
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. |
|
FDA Technical Contact
|
Standards Development Organization
|
FDA Specialty Task Group (STG)
General Plastic Surgery/General Hospital |
|
*These are provided as examples and others may be applicable. |