Hi,
I understood that all blood contacting devices are classified as Class III in FDA. What is the classification of surgical sutures being used for Cardiovascular surgery? Kindly help me.
Cinti
Dear Cinti
Surgical sutures are classified under 21 CFR 878 (
class II), refer below FDA definition
SUBCHAPTER H--MEDICAL DEVICES
PART 878 -- GENERAL AND PLASTIC SURGERY DEVICES
Subpart E--Surgical Devices
Sec. 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.
(a)Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percentl-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. "Monograph for Absorbable Surgical Sutures;" it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved color additive. Also, the suture may be provided with or without a standard needle attached.
(b)Classification. Class II (special controls). The special control for this device is FDA's "Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA." See 878.1(e) for the availability of this guidance document.
[56 FR 47151, Sept. 18, 1991, as amended at 68 FR 32984, June 3, 2003]
Attached is
Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA
Regards
S. Subramaniam