| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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055
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Date of Entry 12/21/2020
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FR Recognition Number
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8-543
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| Standard | |
ASTM F755-19
Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants |
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Scope/Abstract1.1 This specification covers the properties and test methods for porous high-density-polyethylene (HDPE) and porous ultra-high-molecular-weight-polyethylene (UHMWPE) intended for use in surgical implants. The porous polyethylene may be used as a free-standing product or as a coating on a substrate in non-loaded applications.
1.2 Materials covered by this standard can have a broad range of mechanical and morphological properties depending on the starting material and fabrication processes. Therefore no attempt has been made to standardize the properties, and the requirements for a specific application are not within the scope of this standard.
1.3 Evaluation of the tissue response to a porous polyethylene must be completed. Guidance in establishing biocompatibility may be found in the list of references.
1.4 Clinical experience and animal studies have shown that tissue will grow into the open pores of porous polyethylene. The tissue ingrowth into the pores may facilitate the establishment of implant fixation. |
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Extent of Recognition
| Partial recognition. The following part(s) of the standard is (are) not recognized: |
| Appendix X2.2. |
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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.
This standard is recognized in part because:
Appendix X2.2 is in conflict with an existing published final guidance, see section III. C. bullet 2 of the guidance listed below. |
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Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices--Part 1: Evaluation and testing within a risk management process", Issued June 2016. Updated September 2020.
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. |
