Document ID: FDA-2015-D-2148-0009
Agency: fda
Document Type: Notice
Title: Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices; Guidance for Industry and Food and Drug Administration Staff; Availability
Posted Date: 2016-11-18T05:00Z

[Federal Register Volume 81, Number 223 (Friday, November 18, 2016)]
[Notices]
[Pages 81783-81785]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-27842]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-2148]

Submission of Premarket Notifications for Magnetic Resonance 
Diagnostic Devices; 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) is announcing the 
availability of the guidance entitled ``Submission of Premarket 
Notifications for Magnetic Resonance Diagnostic Devices.'' This 
guidance provides a detailed description of the information that should 
be included in a premarket notification for a magnetic resonance 
diagnostic device (MRDD).

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

[[Page 81784]]

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-2148 for ``Submission of Premarket Notifications for 
Magnetic Resonance Diagnostic 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/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 
``Submission of Premarket Notifications for Magnetic Resonance 
Diagnostic 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: Jana Delfino, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 4236, Silver Spring, MD 20993-0002, 301-796-6503; 
or Sunder Rajan, Center for Devices and Radiological Health, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 62, Rm. 1113, 
Silver Spring, MD 20993-0002, 301-796-4194.

SUPPLEMENTARY INFORMATION: 

I. Background

    The purpose of this guidance is to provide a detailed description 
of the information that should be included in a premarket notification 
for an MRDD. This guidance is a recommendation of how to comply with 
certain requirements contained in 21 CFR 807.87 and is intended to be 
used in conjunction with information regarding the content and format 
of a 510(k) premarket notification. The approach outlined in this 
guidance document is intended to facilitate the timely review and 
marketing clearance of MRDDs.
    MRDDs are also electronic products under section 531(2) (21 U.S.C. 
360hh(2)) of Subchapter C (Electronic Product Radiation Control (EPRC)) 
of the Federal Food, Drug and Cosmetic Act (FD&C Act). As such, MRDDs 
are subject to the radiological health requirements in Title 21, 
Subchapter J, parts 1000 through 1050 of the Code of Federal 
Regulations, including applicability of general and specific 
performance standards (parts 1010-1050) and other general requirements 
for reporting and recordkeeping (part 1002), notification and 
corrective actions for defective or non-compliant electronic products 
(parts 1003 and 1004), and importation (part 1005).
    This guidance is applicable to MRDDs as defined in 21 CFR 892.1000. 
An MRDD is intended for general diagnostic use to present images that 
reflect the spatial distribution and/or magnetic resonance spectra that 
reflect frequency and distribution of nuclei exhibiting nuclear 
magnetic resonance. Other physical parameters derived from the images 
and/or spectra may also be produced. The device includes hydrogen-1 
(proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, 
phosphorus-31 spectroscopy, and chemical shift imaging (preserving 
simultaneous frequency and spatial information). MRDDs are class II 
medical devices that require premarket notification and an agency 
determination of substantial equivalence prior to marketing.
    The principal components of current MRDDs include the main magnet, 
shim and gradient systems, radiofrequency transmitter and receiver, 
transmit and receive coils, power supplies, computer and software, 
patient supports, and physiological gating devices. This guidance 
document is applicable to

[[Page 81785]]

premarket notifications for new magnetic resonance imaging (MRI) and 
magnetic resonance spectroscopy systems, components, and accessories, 
and modifications to systems, components, and accessories that could 
significantly affect the safety or effectiveness of the MRDD. The 
information in this guidance document is also applicable to the MRI 
system components of dual-modality devices, such as positron emission 
tomography/MRI systems.
    In the Federal Register of July 14, 2015 (80 FR 41046), FDA 
announced the availability of the draft guidance and interested persons 
were invited to comment by October 13, 2015. FDA has considered the 
comments received, and has incorporated changes suggested by the 
comments, as appropriate.
    This guidance supersedes FDA's guidance entitled ``Guidance for 
Industry: Guidance for the Submissions of Premarket Notifications for 
Magnetic Resonance Diagnostic Devices'' dated November 14, 1998.

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 ``Submission of Premarket Notifications for 
Magnetic Resonance Diagnostic Devices.'' 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 ``Submission of Premarket 
Notifications for Magnetic Resonance Diagnostic Devices'' may send an 
email request to CDRH-Guidance@fda.hhs.gov to receive an electronic 
copy of the document. Please use the document number 340 to identify 
the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This 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 807, subpart E (premarket 
notification), have been approved under OMB control number 0910-0120; 
the collections of information in 21 CFR part 801 (labeling) have been 
approved under OMB control number 0910-0485; the collections of 
information in parts 1002 through 1050 (electronic product 
requirements) have been approved under OMB control number 0910-0025; 
and the collections of information in the guidance document ``Requests 
for Feedback on Medical Device Submissions: The Pre-Submission Program 
and Meetings with Food and Drug Administration Staff'' have been 
approved under OMB control number 0910-0756.

    Dated: November 15, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-27842 Filed 11-17-16; 8:45 am]
BILLING CODE 4164-01-P