Document ID: FDA-2011-D-0305-0058
Agency: fda
Document Type: Notice
Title: Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Guidance for Industry and Food and Drug Administration Staff; Availability
Posted Date: 2013-11-25T05:00Z

[Federal Register Volume 78, Number 227 (Monday, November 25, 2013)]
[Notices]
[Pages 70306-70307]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-28084]

[[Page 70306]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0305]

Distribution of In Vitro Diagnostic Products Labeled for Research 
Use Only or Investigational Use Only: Guidance for Industry and Food 
and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the guidance entitled ``Distribution of In Vitro 
Diagnostic Products Labeled for Research Use Only or Investigational 
Use Only.'' This guidance document is intended for manufacturers and 
distributors of ``for research use only'' (RUO) and ``for 
investigational use only'' (IUO) in vitro diagnostic (IVD) products and 
any other entities who label IVD products, as well as FDA staff.

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 ``Distribution of In Vitro Diagnostic Products 
Labeled for Research Use Only or Investigational Use Only'' 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 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 
301-847-8149. See the SUPPLEMENTARY INFORMATION section for information 
on electronic access to the guidance.
    Submit electronic comments to http://www.regulations.gov. Submit 
written comments concerning this guidance 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 Radiological Health, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 66, Rm. 5676, Silver Spring, MD 20993-0002, 
301-796-4664.
    For questions relating to devices regulated by CBER, contact: 
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 document is intended for manufacturers, and any other 
entities legally responsible for the labeling of IVD products that are 
distributing such products they have labeled RUO or IUO (subsequently 
referred to collectively as ``manufacturers''). This guidance is 
intended to provide the current thinking of CDRH and CBER on when IVD 
products are properly labeled RUO and IUO.
    This guidance is being issued because FDA is concerned that the 
distribution of unapproved and uncleared IVD products labeled RUO or 
IUO, but intended for purposes other than research or investigation 
(for example, for clinical diagnostic use \1\), has led, in some cases, 
to the diagnostic use of products with unproven performance 
characteristics, and with manufacturing controls that are inadequate to 
ensure consistent manufacturing of the finished product. Use of such 
tests for clinical diagnostic purposes may mislead healthcare providers 
and cause serious adverse health consequences to patients who are not 
aware that they are being diagnosed with or treated based on the 
results of tests with research or investigational products. This 
guidance is thus intended to remind manufacturers that RUO and IUO 
labeling must be consistent with the manufacturer's intended use of the 
device.
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    \1\ Throughout this guidance document, references to ``clinical 
diagnostic use'' and ``use in clinical diagnosis'' include use in 
making medical treatment decisions.
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    In the Federal Register of June 1, 2011 (76 FR 31615), FDA 
announced the availability of the draft guidance document under the 
title ``Draft Guidance for Industry and Food and Drug Administration 
Staff: Commercially Distributed In Vitro Diagnostic Products Labeled 
for Research Use Only or Investigational Use Only: Frequently Asked 
Questions.'' Interested persons were invited to comment by August 30, 
2011. The FDA received 55 sets of comments regarding the guidance. As a 
result of these comments, FDA revised the guidance and changed its 
format. Due to these revisions, FDA also changed the name of the 
guidance document.

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 ``Distribution of In Vitro Diagnostic 
Products Labeled for Research Use Only or Investigational Use Only.'' 
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. 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 from CBER 
at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. To receive 
``Distribution of In Vitro Diagnostic Products Labeled for Research Use 
Only or Investigational Use Only'' you may either send an email request 
to dsmica@fda.hhs.gov 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 1723 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 809.10 and part 812 have been 
approved under OMB control numbers 0910-0485 and 0910-0078, 
respectively.

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

[[Page 70307]]

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: November 19, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-28084 Filed 11-22-13; 8:45 am]
BILLING CODE 4160-01-P