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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 058 Date of Entry 05/30/2022 
FR Recognition Number 8-589
Standard
ASTM  F1925-22
Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants
Scope/Abstract
1.1 This specification covers virgin semi-crystalline poly(l-lactide) or poly(d-lactide) homopolymer resins intended for use in surgical implants. This specification also covers semi-crystalline resins of l-lactide copolymerized with other bioabsorbable monomers including, but not limited to, glycolide, d-lactide, and dl-lactide. The poly(l-lactide) or poly(d-lactide) based homopolymers and copolymers covered by this specification possess lactide segments of sufficient length to allow potential for their crystallization upon annealing.

1.2 Since poly(glycolide) is commonly abbreviated as PGA for poly(glycolic acid) and poly(lactide) is commonly abbreviated as PLA for poly(lactic acid), these polymers are commonly referred to as PGA, PLA, and PLA:PGA resins for the hydrolytic byproducts to which they respectively degrade. PLA is a term that carries no stereoisomeric specificity and therefore encompasses both the amorphous atactic/syndiotactic dl-lactide based polymers and copolymers as well as the isotactic d-PLA and l-PLA moieties, each of which carries potential for crystallization. Inclusion of stereoisomeric specificity within the lactic acid based acronyms results in the following: poly(l-lactide) as PlLA for poly(l-lactic acid), poly(d-lactide) as PdLA for poly(d-lactic acid), and poly(dl-lactide) as PdlLA for poly(dl-lactic acid). ...
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
§878.4493 Suture, Absorbable, Synthetic, Polyglycolic Acid Class 2 GAM
N/A Absorbable Coronary Drug-Eluting Stent Class 3 PNY
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
 Jinrong (Jinny) Liu
  FDA/OC/CDRH/OPEQ/OHTII/DHTIIC/
  240-402-3160
  jinrong.liu@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Materials
*These are provided as examples and others may be applicable.
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