[Federal Register Volume 76, Number 105 (Wednesday, June 1, 2011)]
[Notices]
[Pages 31615-31616]
From the Federal Register Online via the Government Publishing 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Draft Guidance for Industry and FDA Staff: Commercially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availability of the draft guidance entitled ``Commercially Distributed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 This draft
guidance document is intended for manufacturers and distributors of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this draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance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ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Commercially Distributed in Vitro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Submit written comments concerning this draft guidance to the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
[email protected] 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