| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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053
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Date of Entry 12/23/2019
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FR Recognition Number
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8-508
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| Standard | |
ASTM F2579-18
Standard Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants |
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Scope/Abstract1.1 This specification covers virgin amorphous poly(lactide) homopolymer and poly(lactide-co-glycolide) copolymer resins intended for use in surgical implants. The poly(dl-lactide) homopolymers covered by this specification are considered to be amorphous (that is, void of crystallinity) and are polymerized either from meso-lactide or from equimolar (racemic) combinations of d-lactide and l-lactide. The poly(dl-lactide-co-glycolide) copolymers covered by this specification are also considered to be amorphous and are co-polymerized from a combination of glycolide and either meso-lactide or racemic quantities of d-lactide and l-lactide, and typically possess nominal mole fractions that equal or exceed 50% lactide.
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. Therefore, specific reference to dl-PLA is essential to appropriately differentiate the amorphous atactic/syndiotactic dl-lactide-based polymers and copolymers covered by this specification. Thus, 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).
1.3 This specification covers virgin amorphous poly(lactide)-based resins able to be fully solvated at 30°C by either methylene chloride (dichloromethane) or chloroform (trichloromethane). This specification is not applicable to lactide-based polymers or copolymers that possess isotactic polymeric segments sufficient in to carry potential for lactide-based crystallization, which are covered by Specification F1925 and typically possess nominal mole fractions that equal or exceed 50% L-lactide. This specification is not applicable to lactide-co-glycolide copolymers that possess glycolide segments sufficient in to deliver potential for glycolide-based crystallization, thereby requiring fluorinated solvents for complete dissolution under room temperature conditions. This specification is specifically not applicable to lactide-co-glycolide copolymers with glycolide mole fractions greater than or equal to 70%(65.3% in mass fraction), which are covered by Specification F2313. This specification is not applicable to block copolymers or to polymers or copolymers synthed from combinations of d-lactide and l-lactide that differ by more than 1.5 total mole percent (1.5% of total moles).
1.4 This specification addresses material characteristics of both poly(dl-lactide) and poly(dl-lactide-co-glycolide) resins intended for use in surgical implants and does not apply to packaged and sterilized finished implants fabricated from these materials.
1.5 As with any material, some characteristics may be altered by processing techniques (such as molding, extrusion, machining, assembly, sterilization, and so forth) required for the production of a specific part or device. Therefore, properties of fabricated forms of this resin should be evaluated independently using appropriate test methods to assure safety and efficacy.
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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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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 Contact
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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. |
