USP 41-NF36:2018

Sutures - Needle Attachment

41-NF36:2018

Standard Organization: USP

USP 41-NF36:2018
<871> Sutures - Needle Attachment

Recognition Number	General Plastic Surgery/General Hospital
Recognition Date	2019-01-14
Recognition List	051
Recognition Number	6-417
Extent	Complete standard
Standards Orgs	USP United States Pharmacopeial Convention, Inc. http://www.usp.org/
STG	General Plastic Surgery/General Hospital
FDA Tech	Maegen Colehour FDA/OMPT/CDRH/ODE/DSD/PRSB1/ 301-796-6436 maegen.colehour@fda.hhs.gov

Rationale:

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Scope:

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Code of Federal Regulations:

Regulation Number	Device Name	Device Class	Product Code
§878.5035	Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene	Class 2	NBY
§878.5030	Suture, Nonabsorbable, Silk	Class 2	GAP
§878.5020	Suture, Nonabsorbable, Synthetic, Polyamide	Class 2	GAR
§878.5010	Suture, Nonabsorbable, Synthetic, Polypropylene	Class 2	GAW
§878.5010	Suture, Surgical, Nonabsorbable, Poly (Vinylidene Fluoride)	Class 2	MXW
§878.5000	Suture, Nonabsorbable, Synthetic, Polyester	Class 2	GAS
§878.5000	Suture, Nonabsorbable, Synthetic, Polyethylene	Class 2	GAT
§878.4840	Suture, Surgical, Absorbable, Polydioxanone	Class 2	NEW
§878.4830	Suture, Absorbable, Natural	Class 2	GAL
§878.4495	Suture, Nonabsorbable, Nitinol	Class 2	NJU
§878.4495	Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile	Class 2	GAQ
§878.4494	Suture, Recombinant Technology	Class 2	NWJ
§878.4493	Suture, Absorbable, Synthetic, Polyglycolic Acid	Class 2	GAM

FDA Guidance:

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.