Food and Drug Administration, HHS.
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled “Class II Special Controls Guidance Document: Tissue Adhesive for the Topical Approximation of Skin.” This guidance document describes a means by which tissue adhesive for the topical approximation of skin may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule to reclassify these device types from class III into class II (special controls).
Submit written or electronic comments on this guidance at any time. General comments on agency guidance documents are welcome at any time.
Submit written requests for single copies of the guidance document entitled “Class II Special Controls Guidance Document: Tissue Adhesive for the Topical Approximation of Skin” to the Division of Small Manufacturers, International, and Consumer Assistance (HFZ-220), Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Dr., Start Printed Page 31130Rockville, MD 20850. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 240-276-3151. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance.
Submit written comments concerning this guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov. Identify comments with the docket number found in brackets in the heading of this document.Start Further Info
FOR FURTHER INFORMATION CONTACT:
George J. Mattamal, Center for Devices and Radiological Health (HFZ-410), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240-276-3619.End Further Info End Preamble Start Supplemental Information
Tissue adhesive for the topical approximation of skin devices are intended for topical closure of surgical incisions, including laparoscopic incisions, and simple traumatic lacerations that have easily approximated skin edges. Tissue adhesives for topical approximation of skin may be used in conjunction with, but not in place of, deep dermal stitches. This device is currently in class III and subject to premarket approval requirements (section 515 of the Federal Food, Drug, and Cosmetic Act (act); 21 U.S.C. 360e).
On August 25, 2006, at a public meeting of FDA's General and Plastic Surgery Devices Panel (the Panel), the Panel unanimously recommended that the tissue adhesive for the topical approximation of skin device be reclassified from class III into class II and recommended that a guidance document, which the Panel thought should include several voluntary consensus standards, be the special control for the device type. FDA considered the Panel's recommendations and, in the Federal Register of July 3, 2007 (72 FR 36398), published a proposed rule to reclassify the tissue adhesive for the topical approximation of skin device into class II. In addition, FDA issued a draft class II special controls guidance document entitled “Class II Special Controls Guidance Document: Tissue Adhesive for the Topical Approximation of Skin” to support the proposed reclassification.
Following publication of the draft guidance, four comments on the guidance were submitted to the FDA. We considered the suggestions and made appropriate revisions, including consideration of the comments on testing the applicator. FDA is now identifying the guidance document entitled “Class II Special Controls Guidance Document: Tissue Adhesive for the Topical Approximation of Skin” as the guidance document that will serve as the special control for this device type.
The guidance document provides a means by which the tissue adhesive for the topical approximation of skin device may comply with the requirement of special controls for this class II device. Following the effective date of the final reclassification rule, any firm submitting a premarket notification (510(k)) for a tissue adhesive for the topical approximation of skin device will need to address the issues covered in the special controls guidance document. However, the firm need only show that its device meets the recommendations of the guidance document or in some other way provides equivalent assurances of safety and effectiveness. This guidance supersedes the guidance entitled “Cyanoacrylate Tissue Adhesive for the Topical Approximation of Skin - Premarket Approval Applications (PMAs),” dated February 13, 2004.
II. Significance of Guidance
This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the agency's current thinking on “Class II Special Controls Guidance Document: Tissue Adhesive for the Topical Approximation of Skin.” It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations.
III. Electronic Access
Persons interested in obtaining a copy of the guidance may do so by using the Internet. To receive “Class II Special Controls Guidance Document: Tissue Adhesive for the Topical Approximation of Skin,” you may either send an e-mail request to email@example.com to receive an electronic copy of the document or send a fax request to 240-276-3151 to receive a hard copy. Please use the document number 1630 to identify the guidance you are requesting.
CDRH maintains an entry on the Internet for easy access to information including text, graphics, and files that may be downloaded to a personal computer with Internet access. Updated on a regular basis, the CDRH home page includes device safety alerts, Federal Register reprints, information on premarket submissions (including lists of approved applications and manufacturers' addresses), small manufacturer's assistance, information on video conferencing and electronic submissions, Mammography Matters, and other device-oriented information. The CDRH Web site may be accessed at http://www.fda.gov/cdrh. A search capability for all CDRH guidance documents is available at http://www.fda.gov/cdrh/guidance.html. Guidance documents are also available at http://www.regulations.gov.
IV. Paperwork Reduction Act of 1995
This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 807, subpart E, have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 801 have been approved under OMB control number 0910-0485; the collections of information in 21 CFR part 812 have been approved under OMB control number 0910-0078; and the collections of information in 21 CFR part 820 have been approved under OMB control number 0910-0073.
Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
Please note that on January 15, 2008, the FDA Division of Dockets Management Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic comments or submissions will be accepted by FDA only through FDMS at http://www.regulations.gov.Start Signature
Dated: May 21, 2008.
Daniel G. Schultz,
Director, Center for Devices and Radiological Health.
[FR Doc. E8-12072 Filed 5-29-08; 8:45 am]
BILLING CODE 4160-01-S