Document ID: FDA-2011-D-0305-0001
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry and FDA Staff: Commercially Distributed In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Frequently Asked Questions; Availability
Posted Date: 2011-06-01T04:00Z

[Federal Register Volume 76, Number 105 (Wednesday, June 1, 2011)]
[Notices]
[Pages 31615-31616]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-13390]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Draft Guidance for Industry and FDA Staff: Commercially 
Distributed In Vitro Diagnostic Products Labeled for Research Use Only 
or Investigational Use Only: Frequently Asked Questions; 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availability of the draft guidance entitled ``Commercially Distributed 
In Vitro Diagnostic Products Labeled for Research Use Only or 
Investigational Use Only: Frequently Asked Questions.'' This draft 
guidance document is intended for manufacturers and distributors of 
research use only (RUO) and investigational use only (IUO) in vitro 
diagnostic (IVD) products and any other entities who label IVD 
products.

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this draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 
by August 30, 2011.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Commercially Distributed in Vitro 
Diagnostic Products Labeled for Research Use Only or Investigational 
Use Only: Frequently Asked Questions'' 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 or 
Office of Communication, Outreach and Development (HFM-40), 1401 
Rockville Pike, suite 200N, Rockville, MD 20852. Send one self-
addressed adhesive label to assist that office in processing your 
request, or fax your request to CDRH at 301-847-8149. 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 http://www.regulations.gov. Identify comments with the 
docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Tonya Wilbon, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg 66, rm. 5663, Silver Spring, MD 20993-0002, 301-796-6224.

FOR QUESTIONS RELATING TO DEVICES REGULATED BY CBER, CONTACT: Stephen 
Ripley (HFM-17), Center for Biologics Evaluation and Research, Food and 
Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 
20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    RUO and IUO IVD products are distinctive in that they are devices 
that may themselves be used in research or investigations on human 
samples that may eventually lead to their clearance or approval for 
clinical diagnostic use, and they also may be marketed for and used in 
the research and investigation of other FDA-regulated products. Thus, 
the manufacturer of an IUO IVD product is not necessarily the sponsor 
of a clinical investigation that uses such an IVD product in a study. 
The manufacturer of such an IUO IVD product may legally distribute the 
product commercially without FDA premarket review, as long as the 
marketing is only for investigational use.
    The marketing of unapproved and uncleared IVD products for purposes 
other than research or investigation (for example, for clinical 
diagnostic use) has led in some cases to diagnostic use of laboratory 
tests with unproven performance characteristics and 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 research or investigational products. FDA is therefore 
issuing this guidance to remind manufacturers of the requirements 
applicable to RUO and IUO IVDs.
    This guidance will clarify the regulatory requirements applicable 
to IVD products intended for research use only or investigational use 
only and will provide the responses of CDRH and CBER to some frequently 
asked questions about how products should and should not be marketed.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance

[[Page 31616]]

practices regulation (21 CFR 10.115). The draft guidance, when 
finalized will represent the Agency's current thinking on '' 
Commercially Distributed In Vitro Diagnostic Products Labeled for 
Research Use Only or Investigational Use Only: 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 draft 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 the 
CBER Internet site at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. To receive '' 
Commercially Distributed In Vitro Diagnostic Products Labeled for 
Research Use Only or Investigational Use Only: Frequently Asked 
Questions,'' you may either send an e-mail 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 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 
809.10 have been approved under OMB control number 0910-0485; the 
collections in 21 CFR part 812 have been approved under OMB control 
number 0910-0078; and the collections of information regarding importer 
entry notice have been approved under OMB control number 0910-0046.

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: May 18, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-13390 Filed 5-31-11; 8:45 am]
BILLING CODE 4160-01-P