[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Submissions; Draft Guidance for Industry and Food and Drug 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availability of the draft guidance entitled ``Reporting of 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of this draft guidance document is to provide recommendations to 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 This draft 
guidance is not final nor is it in effect at this time.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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by April 17, 2014.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Reporting of Computational Modeling 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    Submit electronic comments on the draft guidance to http://www.regulations.gov.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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