Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices; Guidance for Industry and Food and Drug Administration Staff; Availability, 81783-81785 [2016-27842]
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Federal Register / Vol. 81, No. 223 / Friday, November 18, 2016 / Notices
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
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‘‘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 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: https://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 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 Division of Dockets
Management, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Jonathan McKnight, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911.
SUPPLEMENTARY INFORMATION:
I. Background
In accordance with sections 515(d)(4)
and (e)(2) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C.
360e(d)(4) and (e)(2)), notification of an
order approving, denying, or
withdrawing approval of a PMA will
81783
continue to include a notice of
opportunity to request review of the
order under section 515(g) of the FD&C
Act. The 30-day period for requesting
reconsideration of an FDA action under
§ 10.33(b) (21 CFR 10.33(b)) for notices
announcing approval of a PMA begins
on the day the notice is placed on the
Internet. Section 10.33(b) provides that
FDA may, for good cause, extend this
30-day period. Reconsideration of a
denial or withdrawal of approval of a
PMA may be sought only by the
applicant; in these cases, the 30-day
period will begin when the applicant is
notified by FDA in writing of its
decision.
The regulations (21 CFR 814.44(d)
and 814.45(d)) provide that FDA
publish a quarterly list of available
safety and effectiveness summaries of
PMA approvals and denials that were
announced during that quarter. The
following is a list of PMAs approved by
CBER for which safety and effectiveness
summaries were placed on the Internet
from October 1, 2010, through
September 30, 2016. There were no
denial actions during this period. The
list provides the manufacturer’s name,
the product’s generic name or the trade
name, and the approval date.
TABLE 1—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM OCTOBER 1,
2010, THROUGH SEPTEMBER 30, 2016
PMA No., Docket No.
Applicant
Trade name
Approval date
INSTI HIV–1 Antibody Test Kit .......................
GS HIV Combo Ag/Ab EIA .............................
OraQuick® In-Home HIV Test .........................
DPP HIV 1⁄2 Assay ..........................................
Alere DetermineTM HIV–1/2 Ag/Ab Combo ....
CliniMACs CD34 Reagent System .................
Immucor PreciseTypeTM Human Erythrocyte
Antigen Molecular BeadChip Test.
Bio-Rad Geenius HIV 1⁄2 Supplemental Assay
INTERCEPT® Blood System for Plasma ........
INTERCEPT® Blood System for Platelets ......
ADVIA Centaur HIV Ag/Ab Combo (CHIV)
Assay.
BioPlex® 2200 HIV Ag-Ab ...............................
Cobas HIV–1 ...................................................
November 29, 2010.
July 22, 2011.
July 3, 2012.
December 12, 2012.
August 9, 2013.
January 23, 2014.
May 21, 2014.
BP090032, FDA–2015–M–3249
BP100064, FDA–2015–M–3251
BP120001, FDA–2015–M–3253
BP120032, FDA–2015–M–4130
BP120037, FDA–2015–M–3254
BH110018, FDA–2016–M–2210
BP130026, FDA–2014–M–0740
......................
......................
......................
......................
......................
......................
......................
bioLytical Laboratories Inc ..............................
Bio-Rad Laboratories, Inc ...............................
OraSure Technologies, Inc .............................
Chembio Diagnostic Systems, Inc ..................
Alere Scarborough, Inc ...................................
Miltenyi Biotec, Inc ..........................................
BioArray Solutions, Ltd ....................................
BP140120,
BP130076,
BP140143,
BP140103,
......................
......................
......................
......................
Bio-Rad Laboratories, Inc ...............................
Cerus Corporation ...........................................
Cerus Corporation ...........................................
Siemens Healthcare Diagnostics, Inc .............
BP140111, FDA–2015–M–3255 ......................
BP150262, FDA–2015–M–4981 ......................
Bio-Rad Laboratories, Inc ...............................
Roche Molecular Systems, Inc .......................
FDA–2016–M–1072
FDA–2014–M–2304
FDA–2014–M–2305
FDA–2015–M–2100
II. Electronic Access
mstockstill on DSK3G9T082PROD with NOTICES
Persons with access to the Internet
may obtain the documents at https://
www.fda.gov/BiologicsBloodVaccines/
BloodBloodProducts/Approved
Products/PremarketApprovalsPMAs/
default.htm.
Dated: November 14, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–27769 Filed 11–17–16; 8:45 am]
BILLING CODE 4164–01–P
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:
HHS.
ACTION:
VerDate Sep<11>2014
20:21 Nov 17, 2016
Food and Drug Administration,
Jkt 241001
PO 00000
Notice of availability.
Frm 00065
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October 24, 2014.
December 16, 2014.
December 18, 2014.
June 8, 2015.
July 22, 2015.
December 18, 2015.
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).
SUMMARY:
Submit either electronic or
written comments on this guidance at
any time. General comments on Agency
guidance documents are welcome at any
time.
DATES:
E:\FR\FM\18NON1.SGM
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81784
ADDRESSES:
Federal Register / Vol. 81, No. 223 / Friday, November 18, 2016 / Notices
You may submit comments
as follows:
mstockstill on DSK3G9T082PROD with NOTICES
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): 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
https://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
VerDate Sep<11>2014
20:21 Nov 17, 2016
Jkt 241001
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 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: https://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 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 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
PO 00000
Frm 00066
Fmt 4703
Sfmt 4703
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
E:\FR\FM\18NON1.SGM
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Federal Register / Vol. 81, No. 223 / Friday, November 18, 2016 / Notices
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.
mstockstill on DSK3G9T082PROD with NOTICES
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 https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
Guidance documents are also available
at https://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
VerDate Sep<11>2014
20:21 Nov 17, 2016
Jkt 241001
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–D–3004]
Use of The Seafood List To Determine
Acceptable Seafood Names; Draft
Compliance Policy Guide; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or we) is
announcing the availability of a draft
guidance for FDA staff entitled
‘‘Compliance Policy Guide Sec. 540.750
Use of The Seafood List to Determine
Acceptable Seafood Names’’ (the draft
Compliance Policy Guide (CPG)). The
draft CPG, when finalized, will provide
guidance for FDA staff regarding use of
The Seafood List to determine whether
a seafood name is acceptable.
SUMMARY:
Although you can comment on
any CPG at any time (see 21 CFR
10.115(g)(5)), to ensure that we consider
your comment on the draft CPG before
we begin work on the final version of
the CPG, submit either electronic or
written comments on the draft CPG by
January 17, 2017.
DATES:
ADDRESSES:
You may submit comments
as follows:
PO 00000
Frm 00067
Fmt 4703
Sfmt 4703
81785
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): 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–
2016–D–3004 for ‘‘Compliance Policy
Guide Sec. 540.750 Use of The Seafood
List to Determine Acceptable Seafood
Names.’’ 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
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
E:\FR\FM\18NON1.SGM
18NON1
Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: 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): 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 https://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 https://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: https://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 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 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 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at https://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]
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