E9-31307. 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.

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 The guidance supercedes the draft guidance of the same title dated September 30, 2008.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for the Performance Goals and Procedures, Item I.N of the September 27, 2007, commitment letter, FDA agreed to publish draft guidance by September 30, 2008, for medical imaging devices for use with imaging contrast agents or radiopharmaceuticals. Further, the agreement stated that the “draft guidance will be published by the end of FY 2008, and will be subject to a 90-day comment period.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 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.