2010-15417. Guidance for Industry and Food and Drug Administration Staff; In Vitro Diagnostic 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 guidance entitled “In Vitro Diagnostic (IVD) Device Studies—Frequently Asked Questions.” FDA is issuing this guidance to assist manufacturers in developing and conducting studies for IVD devices, particularly those exempt from most of the Investigational Device Exemption (IDE) regulations. The guidance explains data considerations that ultimately will affect the quality of the premarket submission. The draft of this guidance was issued October 25, 2007.

DATES:

Submit either electronic or written 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 of the guidance document entitled “ In Vitro Diagnostic (IVD) Device Studies—Frequently Asked Questions” to the Division of Small Manufacturers, International, and Consumer Assistance, Center for Devices and Radiological Health (CDRH), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993-0002, or to the Office of Communication, Outreach and Development (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to CDRH at 301-847-8149. The guidance may also be obtained by mail by calling CBER at 1-800-835-4709 or 301-827-1800. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance.

Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 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, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 5524, Silver Spring, MD 20993-0002, 301-796-5455; or

Stephen 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 guidance facilitates 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)), industry sponsors and FDA staff often have questions concerning the relevant requirements and appropriate methods for such studies. This guidance provides information about such studies as well as general information about the development, conduct, and responsibilities associated with all IVD studies. CDRH and CBER both have regulatory oversight of IVD devices. Information in this guidance is relevant to IVD devices regulated by either center under chapter I of title 21 of the Code of Federal Regulations, subchapter H.

In the Federal Register of October 25, 2007 (72 FR 60682), FDA announced the availability of the draft guidance. FDA received one comment regarding the use of investigational IVD devices in clinical drug trials. The comment addresses issues outside the scope of this guidance because this guidance makes recommendations for studies to support premarket notifications and approvals of IVD devices and does not address the use of investigational devices in clinical studies designed to evaluate new drug products.

FDA made several minor wording changes to the guidance document in order to improve clarity, however there are no significant, substantive changes.

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 “In Vitro Diagnostic (IVD) Device Studies—Frequently Asked Questions.” 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 “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 301-847-8149 to receive a hard copy. Please use the document number 1587 to identify the guidance you are requesting.

A search capability for all CDRH guidance documents is available at http://www.fda.gov/​MedicalDevices/​DeviceRegulationandGuidance/​GuidanceDocuments/​default.htm. Guidance documents are also available at http://www.regulations.gov or the CBER Internet site at http://www.fda.gov/​BiologicsBloodVaccines/​GuidanceComplianceRegulatoryInformation/​default.htm.

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 U.S.C. 3501-3520). The collections of information in part 807 (21 CFR part 807), subpart E, including § 807.87, have been approved under OMB control no. 0910-0120; the collections of information in 21 CFR part 860 have been approved under OMB control no. 0910-0138; the collections of information in 21 CFR part 812 have been approved under OMB control no. 0910-0078; the collections of information in 21 CFR parts 50 and 56 have been approved under OMB control no. 0910-0130; the collections of information in 21 CFR part 803 have been approved under OMB control no. 0910-0437; the collections of information in 21 CFR part 810 have been approved under OMB control no. 0910-0432; the collections of information in part 814 (21 CFR part 814), subparts B and E, have been approved under OMB control no. 0910-0231; the collections of information in part 814, subpart H, have been approved under OMB control no. 0910-0332; the collections of information in 21 CFR part 820 have been approved under OMB control no. 0910-0073; the collections of information in 21 CFR part 610 have been approved under OMB control nos. 0910-0116 and 0910-0338; and the collections of information in 21 CFR 809.10 have been approved under OMB control no. 0910-0485.

V. Comments

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written comments regarding this document. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Identify comments 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: June 21, 2010.

Leslie Kux,

Acting Assistant Commissioner for Policy.