Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices: Radiology Devices; Class II Special Controls Guidance Document: Bone Sonometers; Availability, 7976-7977 [E6-2078]

Download as PDF 7976 Federal Register / Vol. 71, No. 31 / Wednesday, February 15, 2006 / Notices cprice-sewell on PROD1PC66 with NOTICES systems, but it remains subject to comment in accordance with the agency’s good guidance practices (GGPs). 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 on a 3.5’’ diskette of the guidance document entitled ‘‘Class II Special Controls Guidance Document: Implantable Intra-Aneurysm Pressure Measurement System’’ 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 301–443– 8818. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. 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 https:// www.fda.gov/dockets/ecomments. Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Nelson Anderson, Center for Devices and Radiological Health (HFZ–450), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301–443–8282, ext. 171. SUPPLEMENTARY INFORMATION: I. Background Elsewhere in this issue of the Federal Register, FDA is publishing a final rule classifying an implantable intraaneurysm pressure measurement system into class II (special controls) under section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360c(f)(2)). This guidance document will serve as the special control for implantable intra-aneurysm pressure measurement systems. Section 513(f)(2) of the act provides that any person who submits a premarket notification under section 510(k) of the act (21 U.S.C. 360(k)) for a device that has not previously been classified may, within 30 days after receiving an order classifying the device into class III under section 513(f)(1) of the act, request FDA to classify the device under the criteria set forth in section 513(a)(1) of the act. FDA shall, within 60 days of receiving such a request, classify the device by written VerDate Aug<31>2005 13:17 Feb 14, 2006 Jkt 208001 order. This classification shall be the initial classification of the device. Within 30 days after issuance of an order classifying the device, FDA must publish a notice in the Federal Register announcing such classification. On August 4, 2005, FDA classified the implantable intra-aneurysm measurement system into class III, because it was not substantially equivalent to a device that was introduced into interstate commerce for commercial distribution before May 28, 1976. On August 9, 2005, CardioMEMS, Inc., submitted a petition requesting classification of the CardioMEMS EndoSensor System under section 513(f)(2) of the act to be classified into class II. After review of the information submitted in the petition, FDA determined that the CardioMEMS EndoSensor System can be classified into class II with the establishment of special controls. FDA believes these special controls will provide reasonable assurance of the safety and effectiveness of the device. Therefore, FDA is issuing this guidance document as a level 1 guidance document that is immediately in effect. FDA will consider any comments that are received in response to this notice to determine whether to amend the guidance document. II. Significance of Guidance This guidance is being issued consistent with FDA’s GGPs regulation (21 CFR 10.115). The guidance represents the agency’s current thinking on implantable intra-aneurysm pressure measurement systems. 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 To receive ‘‘Class II Special Controls Guidance Document: Implantable IntraAneurysm Pressure Measurement System’’ by fax machine, call the Center for Devices and Radiological Health (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 (1589) 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 PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 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 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 U.S.C. 3501–3520). The collections of information in this guidance document have been approved under OMB Control. No. 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: February 6, 2006. Linda S. Kahan, Deputy Director, Center for Devices and Radiological Health. [FR Doc. E6–2142 Filed 2–15–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2003D–0420] Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices: Radiology Devices; Class II Special Controls Guidance Document: Bone Sonometers; Availability AGENCY: Food and Drug Administration, HHS. E:\FR\FM\15FEN1.SGM 15FEN1 Federal Register / Vol. 71, No. 31 / Wednesday, February 15, 2006 / Notices ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry and FDA staff entitled ‘‘Class II Special Controls Guidance Document: Bone Sonometers.’’ The draft guidance was developed to support the reclassification of bone sonometers from class III (premarket approval) into class II (special controls). Elsewhere in this issue of the Federal Register, FDA is publishing a proposed rule to reclassify these devices accordingly. This draft guidance is neither final nor is it in effect at this time. DATES: Submit written or electronic comments on the draft guidance by May 16, 2006. ADDRESSES: Submit written requests for single copies on a 3.5″ diskette of the draft guidance document entitled ‘‘Class II Special Controls Guidance Document: Bone Sonometers’’ 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 301–443– 8818. 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 https:// www.fda.gov/dockets/ecomments. Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Robert A. Phillips, Center for Devices and Radiological Health (HFZ–470), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301–594–1212, ext. 130. SUPPLEMENTARY INFORMATION: cprice-sewell on PROD1PC66 with NOTICES I. Background This draft guidance provides FDA’s recommendations to manufacturers of bone sonometers for identifying risks to health and mitigation measures that can be taken to offset those risks. Bone sonometers are devices that transmit ultrasound energy into the human body to measure acoustic properties of bone that indicate overall bone health and fracture risk. These devices were classified into class III by statute (section 513(f)(1) of the Federal Food, Drug, and Cosmetic (the act) (21 U.S.C. VerDate Aug<31>2005 13:17 Feb 14, 2006 Jkt 208001 360e(f)(i))), however, FDA believes that sufficient information exists to establish special controls that, when followed and combined with the general controls of the act, would provide reasonable assurance of the safety and effectiveness of these devices. II. Significance of the Guidance This draft guidance is being issued consistent with FDA’s good guidance practice regulation (21 CFR 10.115). The draft guidance, if finalized, would represent the agency’s current thinking on bone sonometers. It would not create or confer any rights for or on any person and would 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. Paperwork Reduction Act of 1995 This draft 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 U.S.C. 3501–3520). The collections of information addressed in the draft guidance 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), which expires May 31, 2007. The labeling provisions addressed in the draft guidance have been approved by OMB under the PRA under OMB control number 0910–0485 and expires June 30, 2008. 7977 To receive a copy of ‘‘Class II Special Controls Guidance Document: Bone Sonometers,’’ by fax, call the CDRH Facts-On-Demand system at 800–899– 0381 or 301–827–0111 from a touchtone telephone. Press 1 to enter the system. At the second voice prompt, press 1 to order a document. Enter the document number (1547) followed by the pound sign (#). Follow the remaining voice prompts to complete your request. Persons interested in obtaining a copy of the draft guidance may also do so by using the Internet. CDRH maintains a site 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. Dated: January 17, 2006. Linda S. Kahan, Deputy Director, Center for Devices and Radiological Health. [FR Doc. E6–2078 Filed 2–14–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration IV. Comments Interested persons may submit written or electronic comments on the draft guidance to the Division of Dockets Management (see ADDRESSES). Submit a single copy of electronic comments or two paper copies of any mailed comments, except that an individual may submit one paper copy. Identify comments with the docket number found in brackets in the heading of this document. The draft guidance and received comments are available for public examination in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. V. Electronic Access The Center for Devices and Radiological Health (CDRH) Web site may be accessed at https://www.fda.gov/ cdrh. A search capability for all CDRH guidance documents is also available on the Division of Dockets Management Internet site at https://www.fda.gov/ ohrms/dockets. PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 [Docket No. 2003D–0001] (formerly 03D– 0001) Guidance for Industry on Nonclinical Safety Evaluation of Pediatric Drug Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ‘‘Nonclinical Safety Evaluation of Pediatric Drug Products.’’ This document provides guidance on the role and timing of animal studies in the nonclinical safety evaluation of therapeutics intended for the treatment of pediatric patients. The guidance discusses some conditions under which juvenile animals can be meaningful predictors of toxicity in pediatric patients and makes recommendations on nonclinical testing. E:\FR\FM\15FEN1.SGM 15FEN1

Agencies

[Federal Register Volume 71, Number 31 (Wednesday, February 15, 2006)]
[Notices]
[Pages 7976-7977]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-2078]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D-0420]


Draft Guidance for Industry and Food and Drug Administration 
Staff; Medical Devices: Radiology Devices; Class II Special Controls 
Guidance Document: Bone Sonometers; Availability

AGENCY: Food and Drug Administration, HHS.

[[Page 7977]]


ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry and FDA staff entitled 
``Class II Special Controls Guidance Document: Bone Sonometers.'' The 
draft guidance was developed to support the reclassification of bone 
sonometers from class III (premarket approval) into class II (special 
controls). Elsewhere in this issue of the Federal Register, FDA is 
publishing a proposed rule to reclassify these devices accordingly. 
This draft guidance is neither final nor is it in effect at this time.

DATES: Submit written or electronic comments on the draft guidance by 
May 16, 2006.

ADDRESSES: Submit written requests for single copies on a 
3.5 diskette of the draft guidance document entitled ``Class 
II Special Controls Guidance Document: Bone Sonometers'' 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 301-443-8818. 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 https://www.fda.gov/dockets/ecomments. Identify comments 
with the docket number found in brackets in the heading of this 
document.

FOR FURTHER INFORMATION CONTACT: Robert A. Phillips, Center for Devices 
and Radiological Health (HFZ-470), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-1212, ext. 130.

SUPPLEMENTARY INFORMATION:

I. Background

    This draft guidance provides FDA's recommendations to manufacturers 
of bone sonometers for identifying risks to health and mitigation 
measures that can be taken to offset those risks. Bone sonometers are 
devices that transmit ultrasound energy into the human body to measure 
acoustic properties of bone that indicate overall bone health and 
fracture risk. These devices were classified into class III by statute 
(section 513(f)(1) of the Federal Food, Drug, and Cosmetic (the act) 
(21 U.S.C. 360e(f)(i))), however, FDA believes that sufficient 
information exists to establish special controls that, when followed 
and combined with the general controls of the act, would provide 
reasonable assurance of the safety and effectiveness of these devices.

II. Significance of the Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practice regulation (21 CFR 10.115). The draft guidance, if 
finalized, would represent the agency's current thinking on bone 
sonometers. It would not create or confer any rights for or on any 
person and would 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. Paperwork Reduction Act of 1995

    This draft 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 U.S.C. 3501-
3520). The collections of information addressed in the draft guidance 
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), which expires May 31, 
2007. The labeling provisions addressed in the draft guidance have been 
approved by OMB under the PRA under OMB control number 0910-0485 and 
expires June 30, 2008.

IV. Comments

    Interested persons may submit written or electronic comments on the 
draft guidance to the Division of Dockets Management (see ADDRESSES). 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that an individual may submit one paper copy. 
Identify comments with the docket number found in brackets in the 
heading of this document. The draft guidance and received comments are 
available for public examination in the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.

V. Electronic Access

    The Center for Devices and Radiological Health (CDRH) Web site may 
be accessed at https://www.fda.gov/cdrh. A search capability for all 
CDRH guidance documents is also available on the Division of Dockets 
Management Internet site at https://www.fda.gov/ohrms/dockets.
    To receive a copy of ``Class II Special Controls Guidance Document: 
Bone Sonometers,'' by fax, 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 (1547) followed by the pound sign 
(). Follow the remaining voice prompts to complete your 
request.
    Persons interested in obtaining a copy of the draft guidance may 
also do so by using the Internet. CDRH maintains a site 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.

    Dated: January 17, 2006.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E6-2078 Filed 2-14-06; 8:45 am]
BILLING CODE 4160-01-S

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