E7-20982. Draft Guidance for Industry and Food and Drug Administration Staff; In Vitro Diagnostic Device Studies-Frequently Asked Questions; Availability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The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled “Draft Guidance for Industry and FDA Staff; In Vitro Diagnostic (IVD) Device Studies—Frequently Asked Questions.” This draft guidance document contains information to assist manufacturers in developing and conducting studies for IVD devices, particularly those exempt from most of the Investigational Device Exemption (IDE) regulations. This draft guidance is neither final nor is it in effect at this time.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on this draft before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by January 23, 2008.

ADDRESSES:

Submit written requests for single copies of the draft guidance document entitled “Draft Guidance for Industry and FDA Staff; In Vitro Diagnostic (IVD) Device Studies—Frequently Asked Questions” to the Division of Small Manufacturers, International, and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Submit written comments concerning this draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to either http://www.fda.gov/​dockets/​ecomments or http://www.regulations.gov. Identify comments with the docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:

Sally Hojvat, Center for Devices and Radiological Health (HFZ-312), Food and Drug Administration,2098 Gaither Rd, Rockville, MD 20850, 301-594-5940, ext. 114; or

Stephen M. Ripley, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

This draft guidance is intended to facilitate the movement of new IVD technology from the investigational stage to the marketing stage by providing information about the development and conduct of IVD studies that will be submitted to the agency to support premarket notifications and applications. Because many IVD studies are exempt from most of the IDE regulations at part 812 (21 CFR part 812) (§ 812.2(c)(3)), both industry sponsors and FDA staff often have questions concerning the relevant requirements and appropriate methods for such studies. This draft guidance provides information about such studies as well as general information about the development, conduct, and responsibilities associated with all IVD studies. The Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) both have regulatory oversight of IVD devices. Information in this draft guidance is relevant to IVD devices regulated by either center under subchapter H of 21 CFR Chapter I.

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 IVD device studies. 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 draft guidance may do so by using the Internet. To receive “Draft Guidance for Industry and FDA Staff; In Vitro Diagnostic (IVD) Device Studies—Frequently Asked Questions” you may either send an e-mail request to [e-mail] 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 1587 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 http://www.fda.gov/​cdrh. A search capability for all CDRH guidance documents is available at http://www.fda.gov/​cdrh/​guidance.html. Guidance documents are also available on the CBER Internet site at http://www.fda.gov/​cber/​guidelines.htm or 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 PRA). The collections of information in 21 CFR parts 50 and 56 have been approved under OMB control number 0910-0130; the collections of information in 21 CFR part 803 have been approved under OMB control number 0910-0437; the collections of information in 21 CFR 807.87 have been approved under OMB control number 0910-0120; the collections of information in 21 CFR 809.10 have been approved under OMB control number 0910-0485; the collections of information in 21 CFR part 810 have been approved under OMB control number 0910-0432; the collections of information under part 812 have been approved under OMB control number 0910-0078; the collections of information in part 814 (21 CFR part 814), subparts B and E, have been approved under OMB control number 0910-0231; the collections of information in part 814, subpart H, have been approved under OMB control number 0910-0332; and the collections of information in 21 CFR part 820 have been approved under OMB control number 0910-0073.

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: October 18, 2007.

Jeffrey Shuren,

Assistant Commissioner for Policy.