80 FR 41046 - Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability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

Page Range		41046-41047
FR Document		2015-17250

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices.'' This draft guidance provides a detailed description of the information that should be included in a premarket notification for a magnetic resonance diagnostic device (MRDD). This draft guidance is not final nor is it in effect at this time.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 Issue 134 (Tuesday, July 14, 2015)

[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Diagnostic Devices; Draft Guidance for Industry and Food and Drug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availability of a draft guidance entitled ``Submission of Premarket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 This draft
guidance provides a detailed description of the information that should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 This draft guidance is not final nor is it in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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by October 13, 2015.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requests for a single hard copy of the draft guidance document entitled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 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 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

Federal Register / Vol. 80, No. 134 / Tuesday, July 14, 2015 / Notices 41047

heading of this document. Received Dated: July 7, 2015. Triangle Park, NC 27709. Phone: 919–
comments may be seen in the Division Carolyn Baum, 541–9834, fax: (301) 480–3272, email:
of Dockets Management between 9 a.m. Program Analyst, Office of Federal Advisory whiteld@niehs.nih.gov. Hand Deliver/
and 4 p.m., Monday through Friday, and Committee Policy. Courier address: 530 Davis Drive, Room
will be posted to the docket at http:// [FR Doc. 2015–17164 Filed 7–13–15; 8:45 am] K2136, Morrisville, NC 27560.
www.regulations.gov. BILLING CODE 4140–01–P SUPPLEMENTARY INFORMATION:
Dated: July 8, 2015. Preliminary Agenda and Other
Leslie Kux, Meeting Information: A preliminary
Associate Commissioner for Policy.
DEPARTMENT OF HEALTH AND agenda, roster of SACATM members,
HUMAN SERVICES background materials, public comments,
[FR Doc. 2015–17250 Filed 7–13–15; 8:45 am]
and any additional information, when
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Scientific Advisory Committee on SACATM meeting Web site (http://
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Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
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.
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.
FR Citation		80 FR 41046

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 SERVICESFood and Drug Administration

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration