Guidance for Industry and FDA Staff
Preparing Notices of Availability of
Investigational Medical Devices and for
Recruiting Study Subjects
Good Guidance Practice Level 2
Document issued on: March 19, 1999
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health
Office of Compliance
Division of Bioresearch Monitoring Preface
Public Comment:
Comments and suggestions may be submitted at any time for Agency consideration to,
Food and Drug Administration, Center for Devices and Radiological Health, Office of
Compliance, Division of Bioresearch Monitoring, (HFZ-312), 2094 Gaither Road,
Rockville, Maryland  20850.  Comments may not be acted upon by the Agency until the
document is next revised or updated.  For questions regarding the use or interpretation of
this guidance contact Viola Sellman at (301) 594-4723.
Additional Copies:
World Wide Web/CDRH home page at http://www.fda.gov/cdrh or CDRH Facts
on Demand at 1-800-899-0381 or 301-827-0111, specify number 2229 when
prompted for the document shelf number.
Food and Drug Administration
Center for Devices and Radiological Health
November 1985
Revised:  February 1999 Guidance for Industry and FDA Staff on Preparing Notices of Availability of
Investigational Medical Devices and for Recruiting Study Subjects
This guide is intended to clarify section 812.7 of 21 CFR
Part 812, the regulations providing procedures for
investigational device exemptions (OMB CONTROL NUMBER 0910-
0078).  This section prohibits the promotion or test
marketing of investigational medical devices.  Any person
wishing to make known through a notice, publication,
display, mailing, exhibit, announcement, or oral
presentation the availability of an investigational device
for the purpose of obtaining clinical investigators to
participate in a clinical study involving human subjects
should:
1.  Announce the availability of the device only in
medical or scientific publications or at medical
or scientific conferences whose readership or
audience is comprised primarily of experts
qualified by scientific training and experience
to investigate the safety and effectiveness of
devices.
1 2.  State in clear terms that the purpose is only to
obtain investigators and not to make the device
generally available.  Enrolling more
investigators than necessary to evaluate the
safety and effectiveness of the device will be
considered promotion or commercialization of the
device.
3.  Limit the information presented in any notice of
availability to the following:  the proposed use
of the device, the name and address of the
sponsor, how to apply to be an investigator, and
how to obtain the device for investigational use.
The notice should further list the investigators
responsibilities during the course of the
investigation; namely, to await institutional
review board (IRB) and Food and Drug
Administration (FDA) approval before allowing any
subject to participate, to obtain informed
consent from subjects, to permit the device to be
used only with subjects under the investigators
supervision, to report adverse reactions, to keep
accurate records, and, more generally, to conduct
the investigation in accordance with the signed
2 agreement with the sponsor, the investigational
plan, FDAs regulations, and whatever conditions
of approval are imposed by the reviewing IRB or
FDA.
4.  Use direct mailing for the sole purpose of
soliciting qualified experts to conduct
investigations.  (Note: an undirected mass
mailing will not be considered an appropriate
means of soliciting clinical investigators.  Such
a mailing will be considered promotion.)
5.  Include the following statement displayed
prominently and in printing at least as large as
the largest printing in the notice:  Caution 
INVESTIGATIONAL DEVICE, LIMITED BY FEDERAL (OR
UNITED STATES) LAW TO INVESTIGATIONAL USE."
6.  Ensure that no claims are made which state or
imply, directly or indirectly, that the device is
reliable, durable, dependable, safe, or effective
for the purposes under investigation or that the
device is in any way superior to any other
device.
3 7.  Not present comparative descriptions of the
device with other devices but may include
reasonably sized drawings or photographs of the
device.
8.  A sponsor or investigator should not offer volume
discounts for an investigational device.  FDA
would regard such discounts as the promotion of
an investigational device.
When recruiting study subjects, sponsors and investigators
should take the following into consideration:
1.  Direct recruiting advertisements are seen as part of
the informed consent and subject selection process
[see 21 CFR 50.20, 50.25, 56.111(a)(3) and
812.20(b)(11)]. IRB review is necessary to ensure that
the information provided is not misleading to
subjects.  This is especially critical when a study
may involve subjects who are likely to be vulnerable
to undue influence.
4 2.  When direct advertising is used, the IRB should review
the information contained in the advertisement and the
mode of its communication, to determine that the
procedure for recruiting subjects is not coercive and
does not state or imply a certainty of favorable
outcome or other benefits beyond what is outlined in
the consent document and the protocol.
3.  No claims should be made, either explicitly or
implicitly, that the device is safe or effective for
the purposes under investigation, or that the test
article is known to be equivalent or superior to any
device.
4.  Advertising for recruitment into investigational
device studies should not use the term new
treatment, without explaining that the test article
is investigational.  A phrase such as receive new
treatments implies that all study subjects will be
receiving newly marketed products of proven worth.
5 5. Advertisements should not promise free medical
treatment when the intent is only to say subjects
will not be charged for taking part in the
investigation.  Advertisement may state that subjects
will be paid, but should not emphasize the payment or
the amount to be paid.
Generally, FDA believes that any advertisement to recruit
subjects should be limited to the information the
prospective subjects need to determine their eligibility
and interest.  The following should be included in
advertisements, but FDA does not require inclusion of the
listed items:
1. The name and address of the clinical investigator and/or
research facility;
2. The condition under study and/or the purpose of the
research;
3. In summary form, the criteria that will be used to
determine eligibility for the study;
6 4. A brief list of participation benefits, if any (e.g., a
no-cost health examination);
5. The time or other commitment required of the subjects;
and
6. The location of the research and the person or office to
contact for further information.
This guide represents the Agency's current thinking on
preparing notices of availability of investigational
medical devices and for recruiting study subjects.  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, regulations, or
both.
References:
Investigational Device Exemptions Manual (FDA 96-4159)
Title 21 Code of Federal Regulations, Part 812
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