Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Electrocardiograph Electrodes; Availability, 56771-56772 [E7-19578]

Download as PDF Federal Register / Vol. 72, No. 192 / Thursday, October 4, 2007 / Notices Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to either https:// www.fda.gov/dockets/ecomments or https://www.regulations.gov. Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Sheila Murphey, Center for Devices and Radiological Health (HFZ–480), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240–276–3747. SUPPLEMENTARY INFORMATION: I. Background This guidance is for biological indicator devices intended for use in health care facilities to monitor the effectiveness of sterilizers. Biological sterilization process indicators are class II devices identified in 21 CFR 880.2800(a). In the Federal Register of May 21, 2001 (66 FR 27985), FDA invited interested persons to comment on the draft guidance entitled ‘‘Premarket Notifications [510(k)] for Biological Indicators Intended to Monitor Sterilizers Used in Health Care Facilities; Draft Guidance for Industry and FDA Reviewers.’’ FDA received five comments on the draft guidance. Many of the comments are addressed by the voluntary consensus standards that have been recognized by FDA since the draft was issued and that are now cited in the guidance. We addressed comments that suggested the statistics in the validation protocol were too restrictive by clarifying that these statistics are examples, not thresholds. We also revised the guidance for clarity and brevity in response to the comments received. pwalker on PROD1PC71 with NOTICES 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 ‘‘biological indicator premarket notification submissions.’’ 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 ‘‘Biological Indicator (BI) Premarket Notification (510(k)) Submissions’’ you may either send an e-mail request to VerDate Aug<31>2005 16:20 Oct 03, 2007 Jkt 214001 dsmica@fda.hhs.gov 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 1320 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 https://www.fda.gov/cdrh. A search capability for all CDRH guidance documents is available at https:// www.fda.gov/cdrh/guidance.html. Guidance documents are also available on the Division of Dockets Management Internet site at https://www.fda.gov/ ohrms/dockets. 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 USC 3501– 3520). The collections of information in 21 CFR part 807, subpart E have been approved under OMB Control Number 0910–0120. The labeling provisions addressed in the guidance have been approved under OMB Control Number 0910–0485. V. Comments 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. Dated: September 26, 2007. Linda S. Kahan, Deputy Director, Center for Devices and Radiological Health. [FR Doc. E7–19573 Filed 10–3–07; 8:45 am] BILLING CODE 4160–01–S PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 56771 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007N–0309] Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Electrocardiograph Electrodes; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ‘‘Class II Special Controls Guidance Document: Electrocardiograph Electrodes.’’ The draft guidance describes a means by which the electrocardiograph electrode device may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a proposed rule that would designate this draft guidance as the special control for this device and would exempt the device from premarket notification requirements, subject to specific limitations, if the device addresses the issues identified in the guidance by following its recommendations. The draft guidance document is not final, nor is it being implemented 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 written or electronic comments on the draft guidance by January 2, 2008. ADDRESSES: Submit written requests for single copies of the draft guidance document entitled ‘‘Class II Special Controls Guidance Document: Electrocardiograph Electrodes’’ 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 selfaddressed 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. E:\FR\FM\04OCN1.SGM 04OCN1 56772 Federal Register / Vol. 72, No. 192 / Thursday, October 4, 2007 / Notices Submit electronic comments to eitherhttps://www.fda.gov/dockets/ ecomments orhttps:// www.regulations.gov. Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Sharon Lappalainen, Center for Devices and Radiological Health (HFZ–450), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240–276–4095, or by e-mail at Sharon.Lappalainen@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background pwalker on PROD1PC71 with NOTICES In the Federal Register of February 5, 1980 (45 FR 7926), FDA issued a final rule classifying the electrocardiograph electrode into class II, under the Federal Food, Drug, and Cosmetic Act (the act). An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram. FDA has now developed a draft guidance document for the device and, under the act’s provisions, is proposing to designate the draft guidance as the special control that, when combined with the general controls, the agency believes will provide a reasonable assurance of the safety and effectiveness of this device type. Elsewhere in this issue of the Federal Register, FDA is publishing a proposed rule that would designate this draft guidance document as the special control for this device and would exempt the device from premarket notification requirements, subject to limitations in 21 CFR 870.9, if the device addresses the issues identified in the special controls guidance by following the draft guidance’s recommendations. The draft special controls guidance document identifies the classification, product code, and classification identification for the electrocardiograph electrode device. In addition, the draft guidance document identifies the risks to health and serves as a special control that, when followed and combined with the general controls, will generally address the risks associated with this generic device type and permit introduction of the device to the market. 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 VerDate Aug<31>2005 16:20 Oct 03, 2007 Jkt 214001 on the device. 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, regulations, or both. 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: Electrocardiograph Electrodes’’ you may either send an e-mail request to dsmica@fda.hhs.gov 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 (1597) 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 https://www.fda.gov/cdrh. A search capability for all CDRH guidance documents is available at https:// www.fda.gov/cdrh/guidance.html. Guidance documents are also available on the Division of Dockets Management Internet site at https://www.fda.gov/ ohrms/dockets. 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; the collections of information in 21 CFR part 820 have been approved under OMB control number 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), written or electronic PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 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. Dated: September 26, 2007. Linda S. Kahan, Deputy Director, Center for Devices and Radiological Health. [FR Doc. E7–19578 Filed 10–3–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007N–0348] Establishing a Docket for the Development of Safety and Effectiveness Assessments of Vaccines Used for Pandemic Influenza; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the opening of a docket to receive information and comments from manufacturers of vaccines and other interested persons concerning the development of safety and effectiveness assessments of vaccines used for pandemic influenza. FDA is interested in obtaining comments and information to aid in the development of programs for adverse events surveillance following administration of pandemic influenza vaccines, and in the development of protocols to study effectiveness of influenza vaccines in pre-pandemic and pandemic situations. DATES: Submit written or electronic comments on the safety and effectiveness assessments of vaccines for pandemic influenza use, and comments on information submitted to the docket by other interested persons by December 3, 2007. ADDRESSES: Submit written comments and information to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852– 1448. Submit electronic comments or information to either https:// www.fda.gov/dockets/ecomments or https://www.regulations.gov. E:\FR\FM\04OCN1.SGM 04OCN1

Agencies

[Federal Register Volume 72, Number 192 (Thursday, October 4, 2007)]
[Notices]
[Pages 56771-56772]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-19578]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0309]


Draft Guidance for Industry and Food and Drug Administration 
Staff; Class II Special Controls Guidance Document: Electrocardiograph 
Electrodes; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION:  Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the draft guidance entitled ``Class II Special Controls 
Guidance Document: Electrocardiograph Electrodes.'' The draft guidance 
describes a means by which the electrocardiograph electrode device may 
comply with the requirement of special controls for class II devices. 
Elsewhere in this issue of the Federal Register, FDA is publishing a 
proposed rule that would designate this draft guidance as the special 
control for this device and would exempt the device from premarket 
notification requirements, subject to specific limitations, if the 
device addresses the issues identified in the guidance by following its 
recommendations. The draft guidance document is not final, nor is it 
being implemented 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 written or electronic comments on the draft guidance 
by January 2, 2008.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Class II Special Controls Guidance 
Document: Electrocardiograph Electrodes'' 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.

[[Page 56772]]

Submit electronic comments to eitherhttps://www.fda.gov/dockets/
ecomments orhttps://www.regulations.gov. Identify comments with the 
docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Sharon Lappalainen, Center for Devices 
and Radiological Health (HFZ-450), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 240-276-4095, or by e-mail at 
Sharon.Lappalainen@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of February 5, 1980 (45 FR 7926), FDA 
issued a final rule classifying the electrocardiograph electrode into 
class II, under the Federal Food, Drug, and Cosmetic Act (the act). An 
electrocardiograph electrode is the electrical conductor which is 
applied to the surface of the body to transmit the electrical signal at 
the body surface to a processor that produces an electrocardiogram or 
vectorcardiogram. FDA has now developed a draft guidance document for 
the device and, under the act's provisions, is proposing to designate 
the draft guidance as the special control that, when combined with the 
general controls, the agency believes will provide a reasonable 
assurance of the safety and effectiveness of this device type.
    Elsewhere in this issue of the Federal Register, FDA is publishing 
a proposed rule that would designate this draft guidance document as 
the special control for this device and would exempt the device from 
premarket notification requirements, subject to limitations in 21 CFR 
870.9, if the device addresses the issues identified in the special 
controls guidance by following the draft guidance's recommendations.
    The draft special controls guidance document identifies the 
classification, product code, and classification identification for the 
electrocardiograph electrode device. In addition, the draft guidance 
document identifies the risks to health and serves as a special control 
that, when followed and combined with the general controls, will 
generally address the risks associated with this generic device type 
and permit introduction of the device to the market.

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 the device. 
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, regulations, or both.

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: Electrocardiograph Electrodes'' you may either send 
an e-mail request to dsmica@fda.hhs.gov 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 (1597) 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 https://www.fda.gov/
cdrh. A search capability for all CDRH guidance documents is available 
at https://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 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; the collections of 
information in 21 CFR part 820 have been approved under OMB control 
number 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), 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.

    Dated: September 26, 2007.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E7-19578 Filed 10-3-07; 8:45 am]
BILLING CODE 4160-01-S

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.