Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices; Guidance for Industry and Food and Drug Administration Staff; Availability, 81783-81785 [2016-27842]

Download as PDF 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 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. 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 Fmt 4703 Sfmt 4703 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 18NON1 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 18NON1 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]
BILLING CODE 4164-01-P

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