[Federal Register Volume 75, Number 3 (Wednesday, January 6, 2010)]
[Notices]
[Pages 875-876]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-31307]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0525]


Guidance for Industry on New Contrast Imaging Indication 
Considerations for Devices and Approved Drug and Biological Products; 
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 a guidance for industry entitled ``New Contrast Imaging 
Indication Considerations for Devices and Approved Drug and Biological 
Products,'' dated December 2009. As part of the Medical Device User Fee 
Amendments of 2007 (MDUFA) Commitment for the Performance Goals and 
Procedures commitment letter, FDA agreed to publish guidance for 
medical imaging devices for use with imaging contrast agents or 
radiopharmaceuticals. FDA intends this guidance to assist developers of 
medical imaging devices and imaging drug/biological products that 
provide image contrast enhancement. The final guidance announced in 
this document fulfills FDA's commitment to issue guidance called for by 
the commitment letter. The guidance supercedes the draft guidance of 
the same title dated September 30, 2008.

DATES:  Submit written or electronic comments on agency guidances at 
any time.

ADDRESSES:  Submit written requests for single copies of this guidance 
to the Division of Drug Information, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
51, rm. 2201, Silver Spring, MD 20993-0002. Send one self-addressed 
adhesive label to assist that office in processing your requests. 
Submit written comments on the 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. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT:  Patricia Y. Love, Office of 
Combination Products (HFG-3), Office of the Commissioner, Food and Drug 
Administration, 15800 Crabbs Branch Way, Rockville, MD 20855, 301-427-
1934.

SUPPLEMENTARY INFORMATION:

I. Background

    As part of the Medical Device User Fee Amendments of 2007 (MDUFA) 
Commitment for the Performance Goals and Procedures, Item I.N of the 
September 27, 2007, commitment letter, FDA agreed to publish draft 
guidance by September 30, 2008, for medical imaging devices for use 
with imaging contrast agents or radiopharmaceuticals. Further, the 
agreement stated that the ``draft guidance will be published by the end 
of FY 2008, and will be subject to a 90-day comment period. FDA will 
issue a final guidance within one year of the close of the public 
comment period.'' The draft guidance was dated September 30, 2008 (73 
FR 58604, October 7, 2008); the comment period closed on January 5, 
2009. FDA held meetings with imaging industry stakeholders in July 2008 
and August 2009. The final guidance announced in this document fulfills 
FDA's commitment to issue final guidance called for by the commitment 
letter. The guidance supercedes the draft guidance of the same title 
dated September 30, 2008.
    FDA is announcing the availability of guidance for industry 
entitled ``New Contrast Imaging Indication Considerations for Devices 
and Approved Drug and Biological Products.'' FDA intends this guidance 
to assist developers of medical imaging devices and imaging drug/
biological products that provide image contrast enhancement. 
Particularly, this guidance focuses on the following topics: (1) When 
the imaging device developers may add certain new imaging contrast 
indications to their device for use with already approved imaging drugs 
without a need for a modification of the drug labeling, (2) when the 
imaging drug developers may add certain new imaging contrast 
indications to their drug for use with already approved imaging devices 
without a need for a modification of the device labeling, and (3) what 
type of marketing submission(s) imaging drug or imaging device 
developers should submit to FDA to request approval/clearance to add a 
new imaging contrast indication. FDA intends for the recommendations in 
this guidance to promote timely and effective review of, and consistent 
and appropriate regulation and labeling for imaging drugs and devices.
    FDA notes that during the comment period, certain topics identified 
in the docket were beyond the scope of the guidance document. These 
comments included requests for guidance on developing specific medical 
imaging indications (e.g., myocardial perfusion or breast cancer 
imaging) and offered suggestions for the type of acceptable data. FDA 
will consider whether separate guidance would be appropriate.
    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 ``New Contrast Imaging Indication 
Considerations for Devices and Approved Drug and Biological Products''. 
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 
statutes and regulations.
    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 U.S.C. 3501-3520). The 
collections of information in 21 CFR 807 have been approved under

[[Page 876]]

OMB control number 0910-0120. The collections of information in 21 CFR 
814 have been approved under OMB control number 0910-0231. The 
collections of information in 21 CFR 314 have been approved under OMB 
control number 0910-0001.

II. 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.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/RegulatoryInformation/Guidances/ucm122047.htm 
or http://www.regulations.gov.

    Dated: December 30, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-31307 Filed 1-5-10; 8:45 am]
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