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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 055 Date of Entry 12/21/2020 
FR Recognition Number 6-456
Standard
USP 43-NF38:2020
<871> Sutures - Needle Attachment
Scope/Abstract
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
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
§878.4830 Suture, Absorbable, Natural Class 2 GAL
§878.5000 Suture, Nonabsorbable, Synthetic, Polyester Class 2 GAS
§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
§878.4494 Suture, Recombinant Technology Class 2 NWJ
§878.4495 Suture, Nonabsorbable, Nitinol Class 2 NJU
§878.4495 Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile Class 2 GAQ
§878.4840 Suture, Surgical, Absorbable, Polydioxanone Class 2 NEW
§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, Issue August 2007.
FDA Technical Contact
 Maegen Colehour
  FDA/OC/CDRH/OPEQ/OHTIV/DHTIVB/
  301-796-6436
  maegen.colehour@fda.hhs.gov
Standards Development Organization
USP United States Pharmacopeial Convention, Inc. http://www.usp.org/
FDA Specialty Task Group (STG)
General Plastic Surgery/General Hospital
*These are provided as examples and others may be applicable.
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