80 FR 41046 - Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 134 (July 14, 2015)

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices.'' This draft guidance provides a detailed description of the information that should be included in a premarket notification for a magnetic resonance diagnostic device (MRDD). This draft guidance is not final nor is it in effect at this time.

[Federal Register Volume 80, Number 134 (Tuesday, July 14, 2015)]
[Notices]
[Pages 41046-41047]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-17250]


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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Diagnostic Devices; Draft Guidance for Industry and Food and Drug 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availability of a draft guidance entitled ``Submission of Premarket 
Notifications for Magnetic Resonance Diagnostic Devices.'' This draft 
guidance provides a detailed description of the information that should 
be included in a premarket notification for a magnetic resonance 
diagnostic device (MRDD). This draft guidance is not final nor is it in 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by October 13, 2015.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requests for a single hard copy of the draft guidance document entitled 
``Guidance for the 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.
    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: 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 document is to provide a detailed description 
of the information that should be included in a premarket notification 
for an MRDD. This document is an elaboration of the general 
requirements contained in 21 CFR 807.87 and is intended to be used in 
conjunction with general 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.
    This draft 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. 
This draft guidance document is applicable to premarket notifications 
for new magnetic resonance imaging (MRI) and magnetic resonance 
spectroscopy systems, new components, and modifications to systems and 
components that have a significant impact on safety or effectiveness of 
the magnetic resonance diagnostic device. The information in this draft 
guidance document is also applicable to the MRI system components of 
dual-modality devices, such as positron emission tomography/MRI 
systems.

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 ``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 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 ``Submission of Premarket 
Notifications for Magnetic Resonance Diagnostic Devices'' may send an 
email request to [email protected] 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 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 807, subpart E, have been 
approved under OMB control number 0910-0120, and the collections of 
information in 21 CFR part 801 have been approved under OMB control 
number 0910-0485.

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

[[Page 41047]]

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: July 8, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-17250 Filed 7-13-15; 8:45 am]
 BILLING CODE 4164-01-P