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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 040 Date of Recognition 08/14/2015 
FR Recognition Number 6-352
Standard
ASTM F703-07
Standard Specification for Implantable Breast Prostheses
Extent of Recognition
Complete standard
Transition Period
FDA recognition of ASTM F703-07 [Rec# 6-352] will be superseded by recognition of ASTM F703-18 [Rec# 6-409]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 6-352] until September 28, 2019. After this transition period, declarations of conformity to [Rec# 6-352] will not be accepted.
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
There is no relevant guidance developed at this time.
FDA Technical Contact
 George Ngatha
  FDA/OMPT/CDRH/OC/DMQ/ASDB/
  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
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