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Title 21 Part 878 → Subpart E → §878.4010

Title 21 → Chapter I → Subchapter H → Part 878 → Subpart E → §878.4010

Electronic Code of Federal Regulations e-CFR

Title 21 Part 878 → Subpart E → §878.4010

e-CFR data is current as of May 26, 2020

Title 21Chapter ISubchapter HPart 878Subpart E → §878.4010


Title 21: Food and Drugs
PART 878—GENERAL AND PLASTIC SURGERY DEVICES
Subpart E—Surgical Devices


§878.4010   Tissue adhesive.

(a) Tissue adhesive for the topical approximation of skin—(1) Identification. A tissue adhesive for the topical approximation of skin is a device intended for topical closure of surgical incisions, including laparoscopic incisions, and simple traumatic lacerations that have easily approximated skin edges. Tissue adhesives for the topical approximation of skin may be used in conjunction with, but not in place of, deep dermal stitches.

(2) Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: “Tissue Adhesive for the Topical Approximation of Skin.” See §878.1(e) of this chapter for the availability of this guidance document.

(b) Tissue adhesive for non-topical use—(1) Identification. A tissue adhesive for non-topical use, including adhesives intended for use in the embolization of brain arteriovenous malformation or for use in ophthalmic surgery, is a device used for adhesion of internal tissues and vessels.

(2) Classification. Class III (premarket approval). As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See §878.3 of this chapter.

[73 FR 31033, May 30, 2008]