| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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050
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Date of Entry 09/17/2018
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FR Recognition Number
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8-471
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| Standard | |
ASTM F1925-17
Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants |
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Scope/Abstract1.1 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). ... |
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| Extent of Recognition
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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. |
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Transition Period
| FDA recognition of ASTM F1925-17 [Rec# 8-471] will be superseded by recognition of ASTM F1925-22 [Rec# 8-589]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 8-471] until July 9, 2023. After this transition period, declarations of conformity to [Rec# 8-471] will not be accepted. |
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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. |
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| FDA Technical Contacts
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| Standards Development Organization
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| FDA Specialty Task Group (STG)
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| *These are provided as examples and others may be applicable. |
