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U.S. Department of Health and Human Services

Recognized Consensus Standards

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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/Abstract
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.
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
§878.3540 Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled Class 3 FTR
§878.3530 Prosthesis, Breast, Inflatable, Internal, Saline Class 3 FWM
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
 George Ngatha
  FDA/OC/CDRH/OPEQ/OHTIII/DHTIIIA/
  301-796-6444
  george.ngatha@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
General Plastic Surgery/General Hospital
*These are provided as examples and others may be applicable.
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