| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
051
|
Date of Entry 01/14/2019
|
|
FR Recognition Number
|
8-179
|
| Standard | |
ASTM F754-08 (Reapproved 2015)
Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Sheet, Tube, and Rod Shapes Fabricated from Granular Molding Powders |
|
Scope/Abstract1.1 This specification describes the physical, chemical, and mechanical performance requirements for polytetrafluoroethylene (PTFE) pre-fabricated by compression molding or extrusion into sheet, tube, and rod shapes which may be used for implant products.
1.2 PTFE is a high molecular weight straight chain member of the generic class of perfluorocarbon (containing only the elements fluorine and carbon) polymers.
1.3 Perfluorocarbon high polymers exhibit extraordinary thermal and chemical stability and do not require stabilizing additives of any kind.
1.4 This specification applies to primarily void-free molded or extruded PTFE shapes formed from granular molding powders. This specification does not apply to shapes formed from "fine powder" resins by lubricated paste extrusion, which includes expanded PTFE.
1.5 This specification does not apply to specific surgical implant products, including their packaging, sterilization, or material boicompatibility and/or suitability for a particular end-use application. |
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Extent of Recognition
| Partial recognition. The following part(s) of the standard is (are) not recognized: |
| Appendix X2.2 |
|
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. |
|
Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §872.3930 |
Barrier, Synthetic, Intraoral
|
Class 2
|
NPK
|
| §878.3300 |
Mesh, Surgical, Polymeric
|
Class 2
|
FTL
|
| §878.3550 |
Prosthesis, Chin, Internal
|
Class 2
|
FWP
|
| §878.3550 |
Implant, Malar
|
Class 2
|
LZK
|
| §878.3590 |
Prosthesis, Ear, Internal
|
Class 2
|
FZD
|
| §878.3680 |
Prosthesis, Nose, Internal
|
Class 2
|
FZE
|
| §878.5010 |
Suture, Nonabsorbable, Synthetic, Polypropylene
|
Class 2
|
GAW
|
| §878.5010 |
Suture, Surgical, Nonabsorbable, Poly (Vinylidene Fluoride)
|
Class 2
|
MXW
|
|
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.
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 Contacts
|
| Standards Development Organization
|
| FDA Specialty Task Group (STG)
|
| *These are provided as examples and others may be applicable. |
