Recognized Consensus Standards

Recognition List Number: 030 Publication Date: 01/15/2013 

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 6-291: USP 35-NF 35:2012, Absorbable Surgical Suture. (General Plastic Surgery/General Hospital)

Date of Standard: 2012. 

Address of Standards Organization:

  United States Pharmacopeial Convention, Inc. (USP)

  12601 Twinbrook Parkway

  Rockville, MD 20852

CDRH Office and Division Associated with Recognized Standards:

	OFFICE OF DEVICE EVALUATION (ODE)

Devices Affected:

Absorbable Surgical Sutures

Processes Affected:

510(k), IDE, PMA

Type of Standard:

 Vertical, National

Extent of Recognition:

Complete standard

Related CFR Citations and Product Codes:

Regulation Number	Device Name	Device Class	Product Code
§878.4493	Suture, Absorbable, Synthetic, Polyglycolic Acid	Class 2	GAM
Regulation Number	Device Name	Device Class	Product Code
§878.4494	Suture, Recombinant Technology	Class 2	NWJ
Regulation Number	Device Name	Device Class	Product Code
§878.4830	Suture, Absorbable	Class 2	GAK
§878.4830	Suture, Absorbable, Natural	Class 2	GAL
Regulation Number	Device Name	Device Class	Product Code
§878.4840	Suture, Surgical, Absorbable, Polydioxanone	Class 2	NEW

Relevant Guidance:

Guidance for Industry and FDA Staff-Class II Special Controls Guidance Document: Surgical Sutures: Guidance for Industry and FDA. Issued June 3, 2003

Guidance for Industry and FDA Staff-Class II Special Controls Guidance Document: Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by Recombinant DNA Technology: Guidance for Industry and FDA. Issued August 3, 2007

FDA Technical Contact:

  Maegen Colehour

  FDA/CDRH/ODE

  10903 New Hampshire Building 66, Room G423

  Silver Spring MD 20993

  301/796-6436

  Email: maegen.colehour@fda.hhs.gov