2014-18538. In Vitro Companion Diagnostic Devices; Guidance for Industry and FDA Staff; 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 Companion Diagnostic Devices.” This guidance is intended to assist sponsors who are planning to develop a therapeutic product for which the use of an in vitro companion diagnostic device is essential for the therapeutic product's safe and effective use as well as sponsors planning to develop an in vitro companion diagnostic device that is intended to be used with a corresponding therapeutic product.

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:

An electronic copy of the guidance document is available for download from the Internet. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written requests for a single hard copy of the guidance document entitled “In Vitro Companion Diagnostic Devices” to the Office of the Center Director, Guidance and Policy Development, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request. Alternatively, you may submit written requests for single copies of the 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, or Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to the office that you are ordering from to assist in processing your request.

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:

Elizabeth Mansfield, Center for Devices and Radiologic Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5676, Silver Spring, MD 20993-0002, 301-796-4664; or Christopher Leptak, Center for Drug Evaluation and Research, Food and Drug Administration, Bldg. 22, Rm. 6462, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-0017; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

The Food and Drug Administration (FDA) is announcing the availability of a guidance document for industry and FDA staff entitled “In Vitro Companion Diagnostic Devices.” This guidance is intended to assist: (1) Sponsors who are planning to develop a therapeutic product (either a novel product or an existing product with a new indication) for which the use of an in vitro companion diagnostic device (or test) is essential for the therapeutic product's safe and effective use and (2) sponsors planning to develop an in vitro companion diagnostic device that is intended to be used with a corresponding therapeutic product. The guidance defines “in vitro companion diagnostic device” (also referred to as “IVD companion diagnostic device”) and clarifies that in most circumstances, an IVD companion diagnostic device and its corresponding therapeutic product should be approved or cleared contemporaneously by FDA for the use indicated in the therapeutic product labeling.

Diagnostic tests have been used for many years to enhance the use of therapeutic products. Tests are also used during therapeutic product development to obtain the data FDA uses to make regulatory determinations. After a therapeutic product is commercially available for use, health care professionals may use a relevant diagnostic test, for example, to select the appropriate therapy for a particular patient or to optimize a dosing regimen. Recently, the development of therapeutic products for which the use of a diagnostic test is essential for the products to meet their labeled safety and effectiveness claims has become more common. For example, such a test can identify appropriate subpopulations for treatment or identify populations who should not receive a particular treatment because of an increased risk of a serious side effect. These new technologies are making it increasingly possible to individualize, or personalize, medical therapy by identifying patients who are most likely to respond, or who are at varying degrees of risk for a particular side effect.

FDA believes that use of an IVD companion diagnostic device with a therapeutic product raises important concerns about the safety and effectiveness of both the device and the therapeutic product. An erroneous test result could lead to withholding appropriate therapy or to administering inappropriate therapy. Health care professionals must be able to rely on information from IVD companion diagnostic devices to help make critical treatment decisions. FDA oversight of IVD companion diagnostic devices will help protect patients from treatment risks that could arise from IVD companion diagnostic devices that have inadequate performance characteristics.

When an appropriate scientific rationale supports such an approach, FDA encourages the joint development of therapeutic products and diagnostic devices that are essential for the safe and effective use of those therapeutic products. To facilitate the development and approval of therapeutic products that are intended for use with IVD companion diagnostic devices, as well as the development of the IVD companion diagnostic devices themselves, FDA is clarifying relevant policies related to these devices and products.

In the Federal Register of July 14, 2011 (76 FR 41506), FDA announced the availability of the draft guidance document. Interested persons were invited to comment by October 12, 2011 (76 FR 51993). Thirty two sets of comments were received and reviewed by FDA. The guidance was updated to address comments where appropriate.

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 IVD companion diagnostic devices. 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.

III. Electronic Access

Persons interested in obtaining a copy of the guidance may do so by downloading an electronic copy from the Internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at http://www.fda.gov/​MedicalDevices/​DeviceRegulationandGuidance/​GuidanceDocuments/​default.htm, and a search capability for all CBER guidance documents is available at http://www.fda.gov/​BiologicsBloodVaccines/​GuidanceComplianceRegulatoryInformation/​default.htm. Guidance documents are also available at http://www.regulations.gov. Persons unable to download an electronic copy of “In Vitro Companion Diagnostic Devices,” may send an email request to [e-mail] to receive an electronic copy of the document. Please use the document number 1737 to identify the guidance you are requesting.

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 21 CFR part 807 subpart E have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 314 have been approved under OMB control number 0910-0001; the collections of information in 21 CFR part 312 have been approved under OMB control number 0910-0014; the collections of information in 21 CFR part 601 have been approved under OMB control number 0910-0338; the collections of information in 21 CFR part 814, subparts B and E, have been approved under OMB control number 0910-0231; 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 801 and 21 CFR 809.10 have been approved under OMB control number 0910-0485; and the collections of information in 21 CFR 201.56 and 21 CR 201.57 have been approved under OMB control number 0910-0572.

V. Comments

Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of 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, and will be posted to the docket at http://www.regulations.gov.

Dated: July 30, 2014.

Leslie Kux,

Assistant Commissioner for Policy.