2010-22303. Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled “Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters.” The guidance was developed as a special control to support the reclassification of PTCA catheters, other than cutting/scoring PTCA catheters, from class III (premarket approval) into class II (special controls). This guidance describes a means by which PTCA catheters, other than cutting/scoring PTCA catheters, 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 that codifies the reclassification of this device type from class III (premarket approval) into class II (special controls).

DATES:

Submit written or electronic comments on this guidance at any time. General comments on agency guidance documents are welcome at any time.

ADDRESSES:

Submit written requests for single copies of the guidance document entitled “Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters” to the Division of Small Manufacturers, International, and Consumer Assistance (HFZ-220), Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 301-847-8149. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance.

Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Identify comments with the docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:

Kathryn O'Callaghan, Center for Devices and Radiological Health (HFZ-450), Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-6349.

SUPPLEMENTARY INFORMATION:

I. Background

This guidance document was developed as a special control guidance to support the reclassification of PTCA catheters, other than cutting/scoring PTCA catheters, into class II (special controls). The device is intended for balloon dilatation of a hemodynamically significant coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion, treatment of acute myocardial infarction, treatment of in-stent restenosis and/or post-deployment stent expansion. Cutting/scoring PTCA catheters (Product Code: NWX) remain in class III and are subject to premarket approval (PMA) requirements (section 515 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e)).

On December 4, 2000, at a public meeting of FDA's Circulatory System Devices Panel (the Panel), the Panel recommended that PTCA catheters, other than cutting/scoring PTCA catheters and standard PTCA catheters for the treatment of in-stent restenosis and/or post-deployment stent expansion, be reclassified from class III to class II, when indicated for balloon dilatation of a hemodynamically significant coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion, or for treatment of acute myocardial infarction. The Panel recommended a guidance document, labeling, and postmarket surveillance as special controls.

FDA considered the Panel's recommendations and, on May 30, 2008, published a proposed rule to reclassify certain PTCA catheters, including standard PTCA catheters for the treatment of in-stent restenosis and/or post-deployment stent expansion, but not cutting/scoring PTCA catheters, into class II. In addition, FDA issued a draft class II special controls guidance document entitled “Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters” to support the proposed reclassification.

Following publication of the draft guidance, two sets of comments on the guidance were submitted to the FDA. The comments received sought minor clarifications on several pre-clinical testing recommendations, including biocompatibility, shelf-life and performance testing. We considered the suggestions and made appropriate revisions. In addition, the guidance was updated to include more specific recommendations regarding evaluation of coating integrity. FDA is now identifying the guidance document entitled “Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters” as the guidance document that will serve as the special control for this device type.

The guidance document provides a means by which PTCA catheters, other than cutting/scoring PTCA catheters, 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 PTCA catheter 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.

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 standard PTCA catheters. 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 for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters” you may either send an e-mail request to [e-mail] to receive an electronic copy of the document or send a fax request to 301-847-8149 to receive a hard copy. Please use the document number (1608) 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 on the Division of Dockets Management Internet site 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 812 have been approved under OMB control number 0910-0078; the collections of information under CFR parts 50 and 56 have been approved under OMB control number 0910-0130; the collections of information in 21 CFR part 820 have been approved under 0910-0073; and the collections of information in 21 CFR part 801 have been approved under OMB control number 0910-0485.

V. Comments

Interested persons may submit to the Division of Dockets Management (see ADDRESSES), electronic or written comments regarding this document. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Identify comments 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.

Dated: August 31, 2010.

Nancy K. Stade,

Deputy Director for Policy, Center for Devices and Radiological Health.