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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 057 Date of Entry 12/20/2021 
FR Recognition Number 6-468
Standard
USP-NF  M99670_02_01
<881> Tensile Strength
Extent of Recognition
Complete standard
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.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§878.4493 Suture, Absorbable, Synthetic, Polyglycolic Acid Class 2 GAM
§878.4494 Suture, Recombinant Technology Class 2 NWJ
§878.4495 Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile Class 2 GAQ
§878.4495 Suture, Nonabsorbable, Nitinol Class 2 NJU
§878.4830 Suture, Absorbable, Natural Class 2 GAL
§878.4840 Suture, Surgical, Absorbable, Polydioxanone Class 2 NEW
§878.5000 Suture, Nonabsorbable, Synthetic, Polyethylene Class 2 GAT
§878.5010 Suture, Nonabsorbable, Synthetic, Polypropylene Class 2 GAW
§878.5010 Suture, Surgical, Nonabsorbable, Poly (Vinylidene Fluoride) Class 2 MXW
§878.5020 Suture, Nonabsorbable, Synthetic, Polyamide Class 2 GAR
§878.5030 Suture, Nonabsorbable, Silk Class 2 GAP
§878.5035 Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene Class 2 NBY
Relevant FDA Guidance and/or Supportive Publications*
Class II Special Controls Guidance Document: Surgical Sutures - Guidance for Industry and FDA Staff, issued June 2003.

Class II Special Controls Guidance Document: Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by Recombinant DNA Technology - Guidance for Industry and FDA Staff, issued August 2007.

DOI: https://doi.org/10.31003/USPNF_M99670_02_01.

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 Contact
 Maegen Colehour
  FDA/OC/CDRH/OPEQ/OHTIV/DHTIVB/
  301-796-6436
  maegen.colehour@fda.hhs.gov
Standards Development Organization
USP-NF United States Pharmacopeia (USP) and the National Formulary (NF) http://www.uspnf.com/
FDA Specialty Task Group (STG)
General Plastic Surgery/General Hospital
*These are provided as examples and others may be applicable.
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