Document ID: FDA-2019-D-2837-0036
Agency: fda
Document Type: Notice
Title: Testing and Labeling Medical Devices for Safety in the Magnetic Resonance Environment; Guidance for Industry and Food and Drug Administration Staff; Availability
Posted Date: 2021-05-20T04:00Z

[Federal Register Volume 86, Number 96 (Thursday, May 20, 2021)]
[Notices]
[Pages 27444-27446]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-10598]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-2837]

Testing and Labeling Medical Devices for Safety in the Magnetic 
Resonance Environment; Guidance for Industry 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 the final guidance entitled ``Testing and Labeling 
Medical Devices for Safety in the Magnetic Resonance (MR) 
Environment.'' FDA developed this guidance to provide FDA's 
recommendations on the testing needed for assessing the safety and 
compatibility of medical devices in the Magnetic Resonance (MR) 
Environment and the recommended format for Magnetic Resonance Imaging 
(MRI) Safety Information in medical device labeling. This guidance 
document is anticipated to aid in consistency of reviews, testing, and 
MRI safety labeling across a variety of medical devices.

DATES: The announcement of the guidance is published in the Federal 
Register on May 20, 2021.

ADDRESSES: You may submit either electronic or written comments on

[[Page 27445]]

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 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-2019-D-2837 for ``Testing and Labeling Medical Devices for Safety 
in the Magnetic Resonance (MR) Environment.'' 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, 240-402-7500.
     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.govinfo.gov/content/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, 240-402-7500.
    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 
``Testing and Labeling Medical Devices for Safety in the Magnetic 
Resonance (MR) Environment'' 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: Terry Woods, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 2116, Silver Spring, MD 20993-0002, 301-796-2503.

SUPPLEMENTARY INFORMATION:

I. Background

    The MR Environment presents unique safety hazards for patients and 
other persons with devices near or inside an MR system. Ensuring safety 
and effectiveness for a medical device intended to enter the MR 
Environment should be an integral part of the device risk management. 
Appropriate testing and labeling, such as well supported MR Conditional 
labeling, should form the basis of adequate mitigations for the unique 
safety hazards in the MR Environment. This guidance document outlines 
FDA's current thinking on the testing needed for assessing the safety 
and compatibility of medical devices in the MR Environment and the 
recommended format for MRI Safety Information in device labeling. This 
document supersedes FDA Guidance entitled ``Establishing Safety and 
Compatibility of Passive Implants in the Magnetic Resonance (MR) 
Environment'', dated December 11, 2014.
    A notice of availability of the draft guidance appeared in the 
Federal Register of August 2, 2019 (84 FR 37886). FDA considered 
comments received and revised the guidance as appropriate in response 
to the comments, including clarification of approaches for 
radiofrequency heating assessments and associated labeling. Revisions 
were also made to provide more guidance about when gradient induced 
vibration and heating assessments are needed and to include the 
possibility of magnetically induced force and torque causing equipment 
to tip over.
    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 ``Testing and Labeling Medical Devices for 
Safety in the Magnetic Resonance (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.

II. 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-

[[Page 27446]]

radiation-emitting-products. This guidance document is also available 
at https://www.regulations.gov and at https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Persons unable to download 
an electronic copy of ``Testing and Labeling Medical Devices for Safety 
in the Magnetic Resonance (MR) Environment'' may send an email request 
to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the 
document. Please use the document number 2019-16505 and complete title 
to identify the guidance you are requesting.

III. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does 
refer to previously approved FDA collections of information. Therefore, 
clearance by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required for this guidance. The previously approved collections of 
information are subject to review by OMB under the PRA. The collections 
of information in the following FDA regulations and guidance have been 
approved by OMB as listed in the following table:

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                                                           OMB  control
21 CFR part; guidance; or FDA form          Topic               No.
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807, subpart E....................  Premarket                  0910-0120
                                     notification.
814, subparts A through E.........  Premarket approval..       0910-0231
814, subpart H....................  Humanitarian Device        0910-0332
                                     Exemption.
812...............................  Investigational            0910-0078
                                     Device Exemption.
``De Novo Classification Process    De Novo                    0910-0844
 (Evaluation of Automatic Class      classification
 III Designation)''.                 process.
``Requests for Feedback on Medical  Q-submissions.......       0910-0756
 Device Submissions: The Pre-
 Submission Program and Meetings
 with Food and Drug Administration
 Staff''.
801 and 809.......................  Medical Device             0910-0485
                                     Labeling
                                     Regulations.
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    Dated: May 14, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-10598 Filed 5-19-21; 8:45 am]
BILLING CODE 4164-01-P