[Federal Register Volume 79, Number 12 (Friday, January 17, 2014)]
[Notices]
[Pages 3211-3212]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-00874]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-D-1530]
Reporting of Computational Modeling Studies in Medical Device
Submissions; Draft Guidance for Industry and Food and Drug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availability of the draft guidance entitled ``Reporting of
Computational Modeling Studies in Medical Device Submissions.''
Computational modeling and simulation (CM&S) studies are often used by
sponsors as a tool to support medical device applications. The purpose
of this draft guidance document is to provide recommendations to
industry on the formatting, organization, and content of reports of
CM&S studies that are used as valid scientific evidence to support
medical device submissions, and to assist FDA staff in the review of
computational modeling and simulation studies by improving the
consistency and predictability of the review and facilitating full
interpretation and complete review of those studies. This draft
guidance is not final nor is it in effect at this time.
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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by April 17, 2014.
ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Reporting of Computational Modeling
Studies in Medical Device Submissions'' 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 20993-0002.
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Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments 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: Tina Morrison, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1272, Silver Spring, MD 20993-0002, 301-796-6310.
SUPPLEMENTARY INFORMATION:
I. Background
There has been an increased interest in the use of CM&S studies as
a tool to support medical device applications, as evidenced by the
increase in the number of computer modeling test reports submitted in
medical device applications. The Center for Devices and Radiological
Health (CDRH) recognizes that use of CM&S studies are an innovative
means to design, develop, and evaluate medical devices, and has held
five public meetings on the topic in recent years. Information
regarding the most recent meeting, ``FDA/NIH/NSF Workshop on Computer
Models and Validation for Medical Devices,'' June 11-12, 2013, is
available at: http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm346375.htm.
CM&S studies have traditionally been used in the areas of fluid
dynamics (e.g., shear stress and stagnation calculations in ventricular
assist devices), solid mechanics (e.g., maximum stress locations in a
hip implant), electromagnetics and optics (e.g., radiofrequency
dosimetry in magnetic resonance imaging, fluence for fiber optic
spectroscopy devices), ultrasound propagation (e.g., absorbed energy
distribution for therapeutic ultrasound), and thermal propagation
(e.g., radiofrequency and laser ablation devices). The purpose of this
draft guidance document is to provide recommendations to industry on
the formatting, organization, and content of reports of CM&S studies
that are used as valid scientific evidence to support medical device
submissions. Moreover, this draft guidance is intended to help improve
the consistency and predictability of the review of computational
modeling and simulation studies and to better facilitate full
interpretation and complete review of those studies.
The draft guidance provides a general outline of information that
should be included in a CM&S report, written in general terms to
capture reporting for any modality. The guidance also includes five
subject matter appendices that provide more background, structure, and
specific terminology for modeling and simulation modalities that are
widely used in regulatory submissions, including fluid dynamics and
mass transport; solid mechanics; electromagnetics and optics;
ultrasound; and heat transfer.
II. Significance of Guidance
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on ``Reporting
of Computational Modeling Studies in Medical Device Submissions.'' 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. To receive
``Reporting of Computational Modeling Studies in Medical Device
Submissions,'' you may either send an email 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 1807 to identify the guidance you are requesting.
IV. Paperwork Reduction Act of 1995
This draft guidance refers to currently 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 812 have been approved under
OMB control number 0910-0078; the collections of information in 21 CFR
part 807 subpart E have been approved
[[Page 3212]]
under OMB control number 0910-0120; collections of information in 21
CFR part 814 subpart B have been approved under OMB control number
0910-0231; and collections of information in 21 CFR part 814 subpart H
have been approved under OMB control number 0910-0332.
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 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: January 13, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-00874 Filed 1-16-14; 8:45 am]
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