Food and Drug Administration, HHS.
The Food and Drug Administration (FDA) is announcing the availability of the guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm.” This guidance document describes a means by which arrhythmia detector and alarm devices 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 devices from class III into class II (special controls).
Submit written or electronic comments on agency guidances at any time.
Submit written requests for single copies on a 3.5″ diskette of the guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” to the Division of Small Manufacturers, International, and Consumer Assistance (HFZ-220), Center for Devices and Radiological Health (CDRH), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send two self-addressed adhesive labels to assist that office in processing your request, or fax your request to 301-443-8818.
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.fda.gov/dockets/ecomments. Identify comments with the docket number found in brackets in the heading of this document. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Elias Mallis, CDRH (HFZ-450), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-8517, ext 177.End Further Info End Preamble Start Supplemental Information
In the Federal Register of December 13, 2002 (67 FR 76749), FDA announced the availability of a draft of this guidance document and invited interested persons to comment on it by Start Printed Page 61449March 13, 2003. FDA received one comment. The comment suggested that FDA rely on more recent technical standards and, in some cases, suggested alternate methods and standards to those FDA cited in the draft guidance. FDA revised the guidance to reflect the updated technical standards, but declined to incorporate the alternate standards and methods suggested. As discussed next, however, a firm may meet the recommendations of the guidance or in some other way provide equivalent assurances.
The guidance document describes a means by which arrhythmia detector and alarm (including ST-segment measurement and alarm) devices may comply with the requirement of special controls for class II devices. Following the effective date of the final classification rule, any firm submitting a 510(k) premarket notification for the device will need to address the issues covered in the special control guidance. However, the firm need only show that its device meets the recommendations of the guidance or in some other way provides equivalent assurances of safety and effectiveness.
Also in the Federal Register of December 13, 2002 (67 FR 76706), FDA proposed to reclassify the arrhythmia detector and alarm into class II with this guidance document as the special control. FDA did not receive any comments on the proposed rule. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule to reclassify the arrhythmia detector and alarm from class III (premarket approval) to class II (special controls).
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 FDA's current thinking on arrhythmia detector and alarm devices. The guidance 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
To receive “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” by fax machine, call the CDRH Facts-On-Demand system at 800-899-0381 or 301-827-0111 from a touch-tone telephone. Press 1 to enter the system. At the second voice prompt, press 1 to order a document. Enter the document number (1363) followed by the pound sign (#). Follow the remaining voice prompts to complete your request.
Persons interested in obtaining a copy of the guidance may also do so by using the Internet. 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.fda.gov/ohrms/dockets.
IV. Paperwork Reduction Act of 1995
This guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (the PRA) (44 USC 3501-3520). The collections of information addressed in the guidance document have been approved by OMB in accordance with the PRA under the regulations governing premarket notification submissions (21 CFR part 807, subpart E, OMB control number 0910-0120). The labeling provisions addressed in the guidance have been approved by OMB under the PRA 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 at any time. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Comments received may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.Start Signature
Dated: October 2, 2003.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 03-27114 Filed 10-27-03; 8:45 am]
BILLING CODE 4160-01-S