[Federal Register Volume 84, Number 133 (Thursday, July 11, 2019)]
[Notices]
[Pages 33075-33077]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-14765]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-D-0331]
Live Case Presentations During Investigational Device Exemption
Clinical Trials; Guidance for Institutional Review Boards, Industry,
Clinical Investigators, and Food and Drug Administration Staff;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance entitled ``Live Case Presentations
During Investigational Device Exemption (IDE) Clinical Trials.'' The
purpose of this guidance is to provide institutional review boards
(IRBs), industry, clinical investigators, and FDA staff with factors to
consider when evaluating the appropriateness of a live case
presentation within a clinical investigation conducted under an
investigational device exemption (IDE) application. This document
provides guidance on important information about a live case
presentation that should be provided as part of an original IDE
application or a supplement to an IDE application when requesting
inclusion of a live case presentation during a clinical investigation.
DATES: The announcement of the guidance is published in the Federal
Register on July 11, 2019.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets
[[Page 33076]]
Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2014-D-0331 for ``Live Case Presentations During Investigational
Device Exemption (IDE) Clinical Trials.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
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
``Live Case Presentations During Investigational Device Exemption (IDE)
Clinical Trials'' to the Office of Policy, 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.
FOR FURTHER INFORMATION CONTACT: John Doucet, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1535, Silver Spring, MD 20993-0002, 301-796-6474.
SUPPLEMENTARY INFORMATION:
I. Background
A live case presentation is a live or pre-recorded broadcast of a
surgical or percutaneous procedure, typically narrated by the operator
(or a discussant other than the operator), with or without expert panel
and/or audience interaction. Our expectation is that very few
investigations under an IDE will include live case presentations.
However, by increasing awareness of the study for healthcare
professionals and eligible subjects, live case presentations may lead
to new therapies being made available sooner.
This guidance is intended, in part, to improve the quality of
information about live case presentations submitted by sponsors as part
of an investigational plan in an original IDE application or supplement
to an IDE application, or to the IRB for non-significant risk studies,
and to ensure consistency in the review of those submissions. It
describes measures we recommend sponsors take to ensure adequate human
subject protection, followup, reporting, and data analysis for live
case presentations.
FDA considered comments received on the draft guidance that
appeared in the Federal Register of April 17, 2014 (79 FR 21776). FDA
revised the guidance as appropriate in response to the comments.
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
current thinking of FDA on live case presentations during IDE clinical
trials. It does not establish any rights for any person and is not
binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.
This guidance is not subject to Executive Order 12866.
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 https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also
available at https://www.regulations.gov. Persons unable to download an
electronic copy of ``Live Case Presentations During Investigational
Device Exemption (IDE) Clinical Trials'' may send an email request to
[email protected] to receive an electronic copy of the
document. Please use the document number 1736 to identify the guidance
you are requesting.
IV. Paperwork Reduction Act of 1995
This guidance refers to previously approved collections of
information. 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
the following FDA regulations have been approved by OMB as listed in
the following table:
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OMB control
21 CFR part Topic No.
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812............................ Investigational Device 0910-0078
Exemption.
50, 56......................... Protection of Human 0910-0755
Subjects: Informed
Consent; Institutional
Review Boards.
56............................. Institutional Review 0910-0130
Boards.
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[[Page 33077]]
Dated: July 8, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-14765 Filed 7-10-19; 8:45 am]
BILLING CODE 4164-01-P