Food and Drug Administration, HHS.
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance for industry and FDA staff entitled “Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters.” The draft guidance was developed as the special controls to support the reclassification of PTCA catheters, other than cutting/scoring PTCA catheters, from class III (premarket approval) into class II (special controls). This draft guidance describes a means by which PTCA catheters, other than cutting/scoring PTCA catheters, may comply with the requirement of special controls for class II devices.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 issuing for public comment the recommendation of the Circulatory System Devices Panel (the Panel) to reclassify PTCA catheters, other than cutting/scoring PTCA catheters, from class III to class II. This draft guidance is not final nor is it in effect at this time.
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by August 28, 2008.
Submit written requests for single copies of the draft guidance document entitled “Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters” to the Division of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, 1350 Piccard Dr., Rockville, 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Submit written comments concerning this draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.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:
Kathryn O'Callaghan or Suzanne Kaiser, Center for Devices and Radiological Health (HFZ-450), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240-276-4222End Further Info End Preamble Start Supplemental Information
The draft 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.
On September 21, 2000, FDA filed a petition submitted under section 513(f)(3) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360c(f)(3)) from Cook Group Inc. (COOK) requesting reclassification of PTCA catheters from class III into class II. (This reclassification petition did not include cutting or scoring PTCA catheters.) In accordance with section 513(f)(1) of the act, the PTCA catheter was automatically classified into class III because the PTCA catheter was not within a type of device which was introduced or delivered for introduction into interstate commerce for commercial distribution before May 28, 1976, and had not been found substantially equivalent to a device placed in commercial distribution after May 28, 1976, which was subsequently reclassified into class II or class I.
At a public meeting on December 4, 2000, the Panel recommended (seven to one) that PTCA catheters, other than cutting/scoring PTCA catheters, 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 Start Printed Page 31128perfusion; or for treatment of acute myocardial infarction. The Panel believed that class II with special controls, such as this draft guidance document, would reasonably ensure the safety and effectiveness of the device.
The Panel recommended that PTCA catheters for the treatment of in-stent restenosis and/or post-deployment stent expansion not be included because of a lack of sufficient information about this use. Since the Panel meeting, however, additional data regarding this use have become available and have been reviewed by the agency. Following the public meeting, FDA reviewed adverse event reports submitted to FDA's Manufacturer and User Facility Device Experience Database (MAUDE). The agency believes that the types of risks associated with the use of PTCA catheters for the treatment of in-stent restenosis and/or post-deployment stent expansion are similar enough to the risks associated with treatment of de novo lesions, such that the special controls discussed at the Panel meeting, with the addition of recommendations for specific nonclinical performance testing and the recommendation that in-stent restenosis patients be included in the clinical evaluation, when necessary, are adequate to control the risks to health for these devices.
II. Significance of Guidance
This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the agency's current thinking on this topic. 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 draft 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 firstname.lastname@example.org 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 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 at http://www.regulations.gov.
IV. Paperwork Reduction Act of 1995
This draft 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; and the collections of information in 21 CFR part 801 have been approved under OMB control number 0910-0485.
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. E8-12116 Filed 5-29-08; 8:45 am]
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