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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 036 FR Publication Date: 07/09/2014 

Part B: Supplementary Information

Recognition Number 6-334: USP 37-NF32:2014, absorbable surgical suture. (General Plastic Surgery/General Hospital)

Date of Standard: 2014. 
Address of Standards Development Organization:
 United States Pharmacopeial Convention, Inc. (USP)
  12601 Twinbrook Parkway
  Rockville, MD 20852
CDRH Office and Division associated with recognized standards:
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:
Device Name Device
§878.4493 Suture, Absorbable, Synthetic, Polyglycolic Acid Class 2 GAM
§878.4494 Suture, Recombinant Technology Class 2 NWJ
§878.4830 Suture, Absorbable Class 2 GAK
§878.4830 Suture, Absorbable, Natural Class 2 GAL
§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
  10903 New Hampshire Building 66, Room G423
  Silver Spring MD 20993
  email: maegen.colehour@fda.hhs.gov