Source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=38209
Timestamp: 2020-02-19 18:53:59
Document Index: 622701864

Matched Legal Cases: ['§878', '§878', '§878', '§878', '§878', '§878', '§872', '§878', 'art 1']

FR Recognition Number 8-179
ASTM F754-08 (Reapproved 2015)
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.
Appendix X2.2
Appendix X2.2 is in conflict with an existing published final guidance, see section III. C. bullet 2 of the guidance listed below.
§878.5010 Suture, Nonabsorbable, Synthetic, Polypropylene Class 2 GAW
§878.5010 Suture, Surgical, Nonabsorbable, Poly (Vinylidene Fluoride) Class 2 MXW
§878.3680 Prosthesis, Nose, Internal Class 2 FZE
§878.3590 Prosthesis, Ear, Internal Class 2 FZD
§878.3550 Prosthesis, Chin, Internal Class 2 FWP
§878.3300 Mesh, Surgical, Polymeric Class 2 FTL
§872.3930 Barrier, Synthetic, Intraoral Class 2 NPK
§878.3550 Implant, Malar Class 2 LZK
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.