2010-23644. Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance Characteristics of In Vitro

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled “Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Helicobacter pylori .” This draft guidance document provides industry and agency staff with updated recommendations concerning 510(k) submissions for various types of in vitro diagnostic devices (IVDs) intended to be used for detecting Helicobacter pylori ( H. pylori) . This draft guidance is not final nor is it in effect at this time.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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comment of this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by December 22, 2010.

ADDRESSES:

Submit written requests for single copies of the draft guidance document entitled “Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Helicobacter pylori ” to the Division of Small Manufacturers, International, and Consumer Assistance, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 301-847-8149. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance.

Submit electronic comments on the draft guidance to http://www.regulations.gov .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:

Freddie M. Poole, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 5520, Silver Spring, MD 20993-0002, 301-796-5457.

SUPPLEMENTARY INFORMATION:

I. Background

This draft guidance document provides recommendations on developing studies for establishing the performance characteristics of in vitro diagnostic devices for the direct or indirect detection of H. pylori bacteria in human blood, serum, urine, stool, or breath specimens. FDA believes these recommended studies will be relevant for premarket notification (510(k)) submissions for these device types. Detection methods listed in this guidance include blood and urine antibody tests, stool antigen test, carbon-13 (¹³ C) urea breath and blood tests, and the urease test. This draft guidance has been updated since the 1992 guidance document entitled “Review Criteria for Assessment of Laboratory Tests for the Detection of Antibodies to Helicobacter pylori ,” to suggest information that submitters provide that is more appropriate given changes in understanding of the science of detection of H. pylori and to include technologies outside the scope of the old guidance, such as H. pylori urea breath tests and H. pylori antigen detection tests.

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 establishing the performance characteristics of in vitro diagnostic devices for the detection of H. pylori . 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 “Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Helicobacter pylori ” you may either send an email 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 1712 to identify the draft 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 .

IV. Paperwork Reduction Act of 1995

This draft guidance refers to previously approved collections of information found in FDA regulations and guidance documents. 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 part 812 have been approved under OMB control number 0910-0078; the collections of information in 21 CFR part 807, subpart E have been approved under OMB control number 0910-0120; the collections of information in 42 CFR 493.17 have been approved under OMB control number 0910-0607; and the collections of information in 21 CFR 56.115 have been approved under OMB control number 0910-0130.

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: September 16, 2010.

Leslie Kux,

Acting Assistant Commissioner for Policy.