[Federal Register Volume 80, Number 124 (Monday, June 29, 2015)]
[Notices]
[Pages 36996-36997]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-15833]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-2104]


Assessment of Radiofrequency-Induced Heating in the Magnetic 
Resonance Environment for Multi-Configuration Passive Medical Devices; 
Draft Guidance for Industry and Food and Drug Administration Staff; 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 or Agency) is announcing 
the availability of the draft guidance entitled ``Assessment of 
Radiofrequency-Induced Heating in the Magnetic Resonance (MR) 
Environment for Multi-Configuration Passive Medical Devices.'' The 
purpose of this guidance is to provide an assessment paradigm for 
radiofrequency (RF)-induced heating on, or near, multi-component, or 
multi-configuration, passive medical devices in the magnetic resonance 
environment. This draft guidance is not final nor is it in effect at 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 of 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by August 28, 2015.

ADDRESSES: 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requests for a single hard copy of the draft guidance document entitled 
``Assessment of Radiofrequency-Induced Heating in the Magnetic 
Resonance (MR) Environment for Multi-Configuration Passive Medical 
Devices'' to the Office of the Center Director, Guidance and Policy 
Development, Center for Devices and Radiological Health, Food and Drug

[[Page 36997]]

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.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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: Wolfgang Kainz, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 62, Rm. 1129, Silver Spring, MD 20993-0002, 301-661-7595.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance to provide 
an assessment paradigm for RF-induced heating on or near multi-
component or multi-configuration passive medical devices in the MR 
environment. During MR scanning, applied RF excitation pulses induce 
currents that can cause heating of electrically conductive materials. 
RF-induced heating of medical devices made with conductive materials 
may lead to patient burns. To minimize the risk of patient burns during 
MR scanning, sponsors should comprehensively assess devices in all 
configurations and combinations. However, multi-component passive 
devices, such as orthopedic fixation devices, may permit a very large 
number of possible device configurations and combinations of individual 
components. Testing all possibilities may be impracticable and 
unnecessary. This draft guidance provides an approach to identify a 
manageable number of device configurations or combinations for the 
testing of RF-induced heating in the MR environment. Additionally, this 
draft guidance provides recommendations on how to assess RF-induced 
device heating for multi-configuration passive medical devices.

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 current thinking of FDA on the assessment 
of RF-induced heating of multi-component, or multi-configuration, 
passive medical devices in the MR environment. 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.

III. Electronic Access

    Persons interested in obtaining a copy of the draft 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 http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at http://www.regulations.gov. Persons 
unable to download an electronic copy of ``Assessment of 
Radiofrequency-Induced Heating in the Magnetic Resonance (MR) 
Environment for Multi-Configuration Passive Medical Devices'' may send 
an email request to [email protected] to receive an electronic 
copy of the document. Please use the document number 1500001 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. 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 814 have been approved under 
OMB control number 0910-0231.

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: June 23, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-15833 Filed 6-26-15; 8:45 am]
 BILLING CODE 4164-01-P