81 FR 81783 - Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices; Guidance for Industry and Food and Drug Administration Staff; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 223 (November 18, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 223 (November 18, 2016)
| Page Range | 81783-81785 | |
| FR Document | 2016-27842 |
[Federal Register Volume 81, Number 223 (Friday, November 18, 2016)] [Notices] [Pages 81783-81785] From the Federal Register Online [www.thefederalregister.org] [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: 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 [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 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
![Federal Register / Vol. 81, No. 223 / Friday, November 18, 2016 / Notices 81783
Management between 9 a.m. and 4 p.m., information about FDA’s posting of continue to include a notice of
Monday through Friday. comments to public dockets, see 80 FR opportunity to request review of the
• Confidential Submissions—To 56469, September 18, 2015, or access order under section 515(g) of the FD&C
submit a comment with confidential the information at: http://www.fda.gov/ Act. The 30-day period for requesting
information that you do not wish to be regulatoryinformation/dockets/ reconsideration of an FDA action under
made publicly available submit your default.htm. § 10.33(b) (21 CFR 10.33(b)) for notices
comments only as a written/paper Docket: For access to the docket to announcing approval of a PMA begins
submission. You should submit two read background documents or the on the day the notice is placed on the
copies total. One copy will include the electronic and written/paper comments Internet. Section 10.33(b) provides that
information you claim to be confidential received, go to http:// FDA may, for good cause, extend this
with a heading or cover note that states www.regulations.gov and insert the 30-day period. Reconsideration of a
‘‘THIS DOCUMENT CONTAINS docket number, found in brackets in the denial or withdrawal of approval of a
CONFIDENTIAL INFORMATION.’’ The heading of this document, into the PMA may be sought only by the
Agency will review this copy, including ‘‘Search’’ box and follow the prompts
applicant; in these cases, the 30-day
the claimed confidential information, in and/or go to the Division of Dockets
period will begin when the applicant is
its consideration of comments. The Management, 5630 Fishers Lane, rm.
notified by FDA in writing of its
second copy, which will have the 1061, Rockville, MD 20852.
decision.
claimed confidential information FOR FURTHER INFORMATION CONTACT:
redacted/blacked out, will be available Jonathan McKnight, Center for Biologics The regulations (21 CFR 814.44(d)
for public viewing and posted on http:// Evaluation and Research, Food and and 814.45(d)) provide that FDA
www.regulations.gov. Submit both Drug Administration, 10903 New publish a quarterly list of available
copies to the Division of Dockets Hampshire Ave., Bldg. 71, Rm. 7301, safety and effectiveness summaries of
Management. If you do not wish your Silver Spring, MD 20993–0002, 240– PMA approvals and denials that were
name and contact information to be 402–7911. announced during that quarter. The
made publicly available, you can SUPPLEMENTARY INFORMATION: following is a list of PMAs approved by
provide this information on the cover CBER for which safety and effectiveness
sheet and not in the body of your I. Background summaries were placed on the Internet
comments and you must identify this In accordance with sections 515(d)(4) from October 1, 2010, through
information as ‘‘confidential.’’ Any and (e)(2) of the Federal Food, Drug, and September 30, 2016. There were no
information marked as ‘‘confidential’’ Cosmetic Act (the FD&C Act) (21 U.S.C. denial actions during this period. The
will not be disclosed except in 360e(d)(4) and (e)(2)), notification of an list provides the manufacturer’s name,
accordance with 21 CFR 10.20 and other order approving, denying, or the product’s generic name or the trade
applicable disclosure law. For more withdrawing approval of a PMA will 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
BP090032, FDA–2015–M–3249 ...................... bioLytical Laboratories Inc .............................. INSTI HIV–1 Antibody Test Kit ....................... November 29, 2010.
BP100064, FDA–2015–M–3251 ...................... Bio-Rad Laboratories, Inc ............................... GS HIV Combo Ag/Ab EIA ............................. July 22, 2011.
BP120001, FDA–2015–M–3253 ...................... OraSure Technologies, Inc ............................. OraQuick® In-Home HIV Test ......................... July 3, 2012.
BP120032, FDA–2015–M–4130 ...................... Chembio Diagnostic Systems, Inc .................. DPP HIV 1⁄2 Assay .......................................... December 12, 2012.
BP120037, FDA–2015–M–3254 ...................... Alere Scarborough, Inc ................................... Alere DetermineTM HIV–1/2 Ag/Ab Combo .... August 9, 2013.
BH110018, FDA–2016–M–2210 ...................... Miltenyi Biotec, Inc .......................................... CliniMACs CD34 Reagent System ................. January 23, 2014.
BP130026, FDA–2014–M–0740 ...................... BioArray Solutions, Ltd .................................... Immucor PreciseTypeTM Human Erythrocyte May 21, 2014.
Antigen Molecular BeadChip Test.
BP140120, FDA–2016–M–1072 ...................... Bio-Rad Laboratories, Inc ............................... Bio-Rad Geenius HIV 1⁄2 Supplemental Assay October 24, 2014.
BP130076, FDA–2014–M–2304 ...................... Cerus Corporation ........................................... INTERCEPT® Blood System for Plasma ........ December 16, 2014.
BP140143, FDA–2014–M–2305 ...................... Cerus Corporation ........................................... INTERCEPT® Blood System for Platelets ...... December 18, 2014.
BP140103, FDA–2015–M–2100 ...................... Siemens Healthcare Diagnostics, Inc ............. ADVIA Centaur HIV Ag/Ab Combo (CHIV) June 8, 2015.
Assay.
BP140111, FDA–2015–M–3255 ...................... Bio-Rad Laboratories, Inc ............................... BioPlex® 2200 HIV Ag-Ab ............................... July 22, 2015.
BP150262, FDA–2015–M–4981 ...................... Roche Molecular Systems, Inc ....................... Cobas HIV–1 ................................................... December 18, 2015.
II. Electronic Access DEPARTMENT OF HEALTH AND SUMMARY: The Food and Drug
HUMAN SERVICES Administration (FDA) is announcing the
Persons with access to the Internet availability of the guidance entitled
may obtain the documents at http:// Food and Drug Administration ‘‘Submission of Premarket Notifications
www.fda.gov/BiologicsBloodVaccines/ for Magnetic Resonance Diagnostic
BloodBloodProducts/Approved [Docket No. FDA–2015–D–2148] Devices.’’ This guidance provides a
Products/PremarketApprovalsPMAs/ detailed description of the information
default.htm. Submission of Premarket Notifications
for Magnetic Resonance Diagnostic that should be included in a premarket
mstockstill on DSK3G9T082PROD with NOTICES
Dated: November 14, 2016. Devices; Guidance for Industry and notification for a magnetic resonance
Leslie Kux, Food and Drug Administration Staff; diagnostic device (MRDD).
Associate Commissioner for Policy. Availability DATES: Submit either electronic or
[FR Doc. 2016–27769 Filed 11–17–16; 8:45 am]
AGENCY: Food and Drug Administration, written comments on this guidance at
BILLING CODE 4164–01–P HHS. any time. General comments on Agency
guidance documents are welcome at any
ACTION: Notice of availability.
time.
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![Federal Register / Vol. 81, No. 223 / Friday, November 18, 2016 / Notices 81785
premarket notifications for new review by the Office of Management and Electronic Submissions
magnetic resonance imaging (MRI) and Budget (OMB) under the Paperwork Submit electronic comments in the
magnetic resonance spectroscopy Reduction Act of 1995 (44 U.S.C. 3501– following way:
systems, components, and accessories, 3520). The collections of information in • Federal eRulemaking Portal: http://
and modifications to systems, 21 CFR part 807, subpart E (premarket www.regulations.gov. Follow the
components, and accessories that could notification), have been approved under instructions for submitting comments.
significantly affect the safety or OMB control number 0910–0120; the Comments submitted electronically,
effectiveness of the MRDD. The collections of information in 21 CFR including attachments, to http://
information in this guidance document part 801 (labeling) have been approved www.regulations.gov will be posted to
is also applicable to the MRI system under OMB control number 0910–0485; the docket unchanged. Because your
components of dual-modality devices, the collections of information in parts comment will be made public, you are
such as positron emission tomography/ 1002 through 1050 (electronic product solely responsible for ensuring that your
MRI systems. requirements) have been approved comment does not include any
In the Federal Register of July 14, under OMB control number 0910–0025; confidential information that you or a
2015 (80 FR 41046), FDA announced the and the collections of information in the third party may not wish to be posted,
availability of the draft guidance and guidance document ‘‘Requests for such as medical information, your or
interested persons were invited to Feedback on Medical Device anyone else’s Social Security number, or
comment by October 13, 2015. FDA has Submissions: The Pre-Submission confidential business information, such
considered the comments received, and Program and Meetings with Food and as a manufacturing process. Please note
has incorporated changes suggested by Drug Administration Staff’’ have been that if you include your name, contact
the comments, as appropriate. approved under OMB control number
This guidance supersedes FDA’s information, or other information that
0910–0756. identifies you in the body of your
guidance entitled ‘‘Guidance for
Industry: Guidance for the Submissions
Dated: November 15, 2016. comments, that information will be
of Premarket Notifications for Magnetic Leslie Kux, posted on http://www.regulations.gov.
Associate Commissioner for Policy. • If you want to submit a comment
Resonance Diagnostic Devices’’ dated
with confidential information that you
November 14, 1998. [FR Doc. 2016–27842 Filed 11–17–16; 8:45 am]
do not wish to be made available to the
BILLING CODE 4164–01–P
II. Significance of Guidance public, submit the comment as a
This guidance is being issued written/paper submission and in the
consistent with FDA’s good guidance DEPARTMENT OF HEALTH AND manner detailed (see ‘‘Written/Paper
practices regulation (21 CFR 10.115). HUMAN SERVICES Submissions’’ and ‘‘Instructions’’).
The guidance represents the current Written/Paper Submissions
thinking of FDA on ‘‘Submission of Food and Drug Administration
Premarket Notifications for Magnetic Submit written/paper submissions as
Resonance Diagnostic Devices.’’ It does follows:
[Docket No. FDA–2016–D–3004]
not establish any rights for any person • Mail/Hand delivery/Courier (for
and is not binding on FDA or the public. Use of The Seafood List To Determine written/paper submissions): Division of
You can use an alternative approach if Acceptable Seafood Names; Draft Dockets Management (HFA–305), Food
it satisfies the requirements of the Compliance Policy Guide; Availability and Drug Administration, 5630 Fishers
applicable statutes and regulations. Lane, Rm. 1061, Rockville, MD 20852.
AGENCY: Food and Drug Administration, • For written/paper comments
III. Electronic Access submitted to the Division of Dockets
HHS.
Persons interested in obtaining a copy Management, FDA will post your
of the guidance may do so by ACTION: Notice of availability. comment, as well as any attachments,
downloading an electronic copy from except for information submitted,
the Internet. A search capability for all SUMMARY: The Food and Drug marked and identified, as confidential,
Center for Devices and Radiological Administration (FDA or we) is if submitted as detailed in
Health guidance documents is available announcing the availability of a draft ‘‘Instructions.’’
at http://www.fda.gov/MedicalDevices/ guidance for FDA staff entitled Instructions: All submissions received
DeviceRegulationandGuidance/ ‘‘Compliance Policy Guide Sec. 540.750 must include the Docket No. FDA–
GuidanceDocuments/default.htm. Use of The Seafood List to Determine 2016–D–3004 for ‘‘Compliance Policy
Guidance documents are also available Acceptable Seafood Names’’ (the draft Guide Sec. 540.750 Use of The Seafood
at http://www.regulations.gov. Persons Compliance Policy Guide (CPG)). The List to Determine Acceptable Seafood
unable to download an electronic copy draft CPG, when finalized, will provide Names.’’ Received comments will be
of ‘‘Submission of Premarket guidance for FDA staff regarding use of placed in the docket and, except for
Notifications for Magnetic Resonance The Seafood List to determine whether those submitted as ‘‘Confidential
Diagnostic Devices’’ may send an email a seafood name is acceptable. Submissions,’’ publicly viewable at
request to CDRH-Guidance@fda.hhs.gov http://www.regulations.gov or at the
DATES: Although you can comment on
to receive an electronic copy of the Division of Dockets Management
any CPG at any time (see 21 CFR
document. Please use the document between 9 a.m. and 4 p.m., Monday
10.115(g)(5)), to ensure that we consider
through Friday.
mstockstill on DSK3G9T082PROD with NOTICES
number 340 to identify the guidance your comment on the draft CPG before
you are requesting. • Confidential Submissions—To
we begin work on the final version of
submit a comment with confidential
IV. Paperwork Reduction Act of 1995 the CPG, submit either electronic or
information that you do not wish to be
written comments on the draft CPG by
This guidance refers to previously made publicly available, submit your
January 17, 2017.
approved collections of information comments only as a written/paper
found in FDA regulations. These ADDRESSES: You may submit comments submission. You should submit two
collections of information are subject to as follows: copies total. One copy will include the
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Document Created: 2018-02-14 08:32:00
Document Modified: 2018-02-14 08:32:00
| 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 of availability. | |
| Dates | Submit either electronic or written comments on this guidance at any time. General comments on Agency guidance documents are welcome at any time. | |
| 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 | 81 FR 81783 |
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