[Federal Register Volume 76, Number 200 (Monday, October 17, 2011)]
[Notices]
[Page 64228]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-26630]



  Federal Register / Vol. 76, No. 200 / Monday, October 17, 2011 / 
Notices  

[[Page 64228]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0649]


Draft Guidance for Industry and Food and Drug Administration 
Staff; Class II Special Controls Guidance Document: External Pacemaker 
Pulse Generator; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the draft guidance entitled ``Class II Special Controls 
Guidance Document: External Pacemaker Pulse Generator.'' This draft 
guidance document describes a means by which external pacemaker pulse 
generators may comply with the requirement of special controls for 
class II devices. This draft guidance is not final nor is it in effect 
at this time.

DATES: 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by January 17, 2012.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Class II Special Controls Guidance 
Document: External Pacemaker Pulse Generator'' to the Division of Small 
Manufacturers, International and Consumer Assistance, 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to the draft guidance.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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: Elias Mallis,Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 4622, Silver Spring, MD 20993-0002, 301-796-6216.

I. Background

    This draft guidance document was developed as a special control 
guidance to support the reclassification of external pacemaker pulse 
generators into class II (special controls). This draft guidance 
document will serve as the special control for external pacemaker pulse 
generators. Section 513(f)(3) of the Federal Food, Drug, and Cosmetic 
Act (the FD&C Act) provides that the Agency may initiate the 
reclassification of a device. This classification will be a 
reclassification of the device. FDA must publish a notice in the 
Federal Register announcing this reclassification. Elsewhere in this 
issue of the Federal Register, FDA is publishing a proposed rule to 
reclassify this device type from class III into class II (special 
controls), under section 513(e) of the FD&C Act (21 U.S.C. 360c(e)).
    FDA is issuing this guidance document as a level 1 draft guidance 
document. FDA will consider any comments that are received within 90 
days of the issuance of this notice to determine whether to revise the 
guidance document.

II. Significance of Special Controls Guidance Document

    FDA believes that adherence to the recommendations described in 
this draft guidance document, when finalized, in addition to the 
general controls, will provide reasonable assurance of the safety and 
effectiveness of external pacemaker pulse generator classified under 
Sec.  870.3600 (21 CFR 870.3600). If classified as a class II device 
under Sec.  870.3600, an external pacemaker pulse generator will need 
to comply with the requirement for special controls; manufacturers will 
need to address the issues requiring special controls as identified in 
the guidance document or by some other means that provides equivalent 
assurances of safety and effectiveness.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do 
so by using the Internet. A search capability for all CDRH guidance 
documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at http://www.regulations.gov. To receive 
``Class II Special Controls Guidance Document: External Pacemaker Pulse 
Generator,'' you may either send an email request to [email protected] 
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 
1769 to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to currently 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 are currently 
approved under OMB control number 0910-0120; the collections of 
information in 21 CFR 56.115 are currently approved under OMB control 
number 0910-0130; the collections of information in 21 CFR part 812 are 
currently approved under OMB control number 0910-0078; and the 
collections of information in 21 CFR part 801 are currently approved 
under OMB control number 0910-0485.

V. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES), either 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: October 11, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-26630 Filed 10-13-11; 8:45 am]
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