81 FR 15310 - Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance Environment for Multi-Configuration Passive Medical Devices; Guidance for Industry and Food and Drug Administration Staff; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 55 (March 22, 2016)

The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical Devices.'' FDA is confronted with an increasing number of premarket submissions that include an MR Conditional labeling claim for multiconfiguration passive medical devices. The assessment of radiofrequency (RF)-induced heating of such devices, typically comprised of many parts, strongly depends on the specific device geometry and can therefore lead to a prohibitively large number of test cases. This guidance provides an approach to reduce the number of possible device configurations to a manageable number, and it provides guidance on how to assess the RF-induced device heating for an individual configuration.

[Federal Register Volume 81, Number 55 (Tuesday, March 22, 2016)]
[Notices]
[Pages 15310-15311]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-06361]


-----------------------------------------------------------------------

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; 
Guidance for Industry and Food and Drug Administration Staff; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of the guidance entitled ``Assessment of 
Radiofrequency-Induced Heating in the Magnetic Resonance (MR) 
Environment for Multi-Configuration Passive Medical Devices.'' FDA is 
confronted with an increasing number of premarket submissions that 
include an MR Conditional labeling claim for multiconfiguration passive 
medical devices. The assessment of radiofrequency (RF)-induced heating 
of such devices, typically comprised of many parts, strongly depends on 
the specific device geometry and can therefore lead to a prohibitively 
large number of test cases. This guidance provides an approach to 
reduce the number of possible device configurations to a manageable 
number, and it provides guidance on how to assess the RF-induced device 
heating for an individual configuration.

DATES: Submit either electronic or written comments on this guidance at 
any time. General comments on Agency guidance documents are welcome at 
any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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-2015-D-2104 for ``Assessment of Radiofrequency-Induced Heating in 
the Magnetic Resonance (MR) Environment for Multi-Configuration Passive 
Medical Devices.'' Received comments will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at http://www.regulations.gov or at the Division of Dockets 
Management 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 http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/

[[Page 15311]]

regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    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 
``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 
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: Wolfgang Kainz, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 62, Rm. 1115, Silver Spring, MD 20993-0002, 301-661-7595.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance to provide an 
assessment paradigm for RF-induced heating on or near multicomponent or 
multiconfiguration 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, multicomponent 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 impractical and 
unnecessary. This 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 
guidance provides recommendations on how to assess the RF-induced 
device heating for multiconfiguration passive medical devices.
    In the Federal Register of June 29, 2015 (80 FR 36996), the Agency 
announced the issuance of the draft guidance entitled ``Assessment of 
Radiofrequency-Induced Heating in the Magnetic Resonance (MR) 
Environment for Multi-Configuration Passive Medical Devices.'' 
Interested persons were invited to comment by August 28, 2015.

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 the assessment of RF-induced heating of 
multicomponent, or multiconfiguration, 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 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 and guidance. 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, subparts B 
and E, are approved under OMB control number 0910-0231; the collections 
of information in 21 CFR part 814, subpart H, are approved under OMB 
control number 0910-0332; the collections of information in 21 CFR part 
807, subpart E, are approved under OMB control number 0910-0120; the 
collections of information in 21 CFR part 812 are approved under OMB 
control number 0910-0078; the collections of information in 21 CFR 
parts 801 and 809 are approved under OMB control number 0910-0485; and 
the collections of information in the guidance document entitled 
``Requests for Feedback on Medical Device Submissions: The Pre-
Submission Program and Meetings with Food and Drug Administration 
Staff'' are approved under OMB control number 0910-0756.

    Dated: March 16, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-06361 Filed 3-21-16; 8:45 am]
 BILLING CODE 4164-01-P