Pediatric Information for X-Ray Imaging Device Premarket Notifications; Guidance for Industry and Food and Drug Administration Staff; Availability, 56248-56250 [2017-25632]

Download as PDF 56248 Federal Register / Vol. 82, No. 227 / Tuesday, November 28, 2017 / Notices received a patent term restoration application for YONDELIS (U.S. Patent No. 7,420,051) from Pharma Mar, S.A., and the USPTO requested FDA’s assistance in determining this patent’s eligibility for patent term restoration. In a letter dated August 25, 2016, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of YONDELIS represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product’s regulatory review period. ethrower on DSK3G9T082PROD with NOTICES II. Determination of Regulatory Review Period FDA has determined that the applicable regulatory review period for YONDELIS is 7,107 days. Of this time, 6,773 days occurred during the testing phase of the regulatory review period, while 334 days occurred during the approval phase. These periods of time were derived from the following dates: 1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became effective: May 10, 1996. FDA has verified the applicant’s claim that the date the investigational new drug application became effective was on May 10, 1996. 2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the FD&C Act: November 24, 2014. FDA has verified the applicant’s claim that the new drug application (NDA) for YONDELIS (NDA 207953) was initially submitted on November 24, 2014. 3. The date the application was approved: October 23, 2015. FDA has verified the applicant’s claim that NDA 207953 was approved on October 23, 2015. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,471 days of patent term extension. III. Petitions Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as specified in § 60.30 (21 CFR 60.30), any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence VerDate Sep<11>2014 19:51 Nov 27, 2017 Jkt 244001 during the regulatory review period. To meet its burden, the petition must comply with all the requirements of § 60.30, including but not limited to: Must be timely (see DATES), must be filed in accordance with § 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41–42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Submit petitions electronically to https://www.regulations.gov at Docket No. FDA–2013–S–0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Dated: November 22, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017–25683 Filed 11–27–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–D–0384] Pediatric Information for X-Ray Imaging Device Premarket Notifications; Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ‘‘Pediatric Information for X-ray Imaging Device Premarket Notifications.’’ This guidance document outlines FDA’s current thinking on information that should be provided in premarket notification submissions for x-ray imaging devices that are indicated for pediatric populations or general use x-ray imaging devices for which considerable pediatric application is anticipated. FDA intends for this guidance to minimize uncertainty during the premarket review process of premarket notification submissions for x-ray imaging devices for pediatric use to encourage the inclusion of pediatric indications for use for x-ray imaging device premarket notification submissions and to provide recommendations on information to SUMMARY: PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 support such indications. Both new devices and modifications of existing xray imaging devices that require submission of a new premarket notification are included within the scope of this guidance document, regardless of whether the device is a complete x-ray imaging system, a component part of an x-ray imaging device, or an accessory (e.g., detectors and software). DATES: The announcement of the guidance is published in the Federal Register on November 28, 2017. ADDRESSES: You may submit either electronic or written comments on Agency guidances at any time 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): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, 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– E:\FR\FM\28NON1.SGM 28NON1 ethrower on DSK3G9T082PROD with NOTICES Federal Register / Vol. 82, No. 227 / Tuesday, November 28, 2017 / Notices 2012–D–0384 for ‘‘Pediatric Information for X-ray Imaging Device Premarket Notifications.’’ 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 Dockets Management Staff 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 Dockets Management Staff. 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.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf. 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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). 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 ‘‘Pediatric Information for X-ray Imaging Device VerDate Sep<11>2014 19:51 Nov 27, 2017 Jkt 244001 Premarket Notifications’’ 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 selfaddressed adhesive label to assist that office in processing your request. FOR FURTHER INFORMATION CONTACT: Laurel Burk, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4268, Silver Spring, MD 20993–0002, 301–796–5933. SUPPLEMENTARY INFORMATION: I. Background This guidance document outlines the current thinking of FDA regarding information that should be provided in premarket notification submissions (510(k)s) and device labeling for x-ray imaging devices that are indicated for pediatric populations or general use xray imaging devices for which considerable pediatric application is anticipated. General use x-ray imaging devices typically neither include nor exclude specific populations in the indications for use and may be expected to be used in any population. Because a large percentage of the hundreds of millions of x-ray examinations performed annually in the United States are exams of pediatric patients, FDA expects that most general use x-ray imaging devices will be used for a considerable quantity of pediatric examinations unless a device’s design precludes use in smaller sized patients. This guidance is intended to enhance clarity regarding the premarket review process of 510(k)s for x-ray imaging devices, to encourage the inclusion of pediatric indications for use for x-ray imaging device 510(k)s, and to provide recommendations regarding labeling, including the instructions for use. In February 2010, FDA launched an ‘‘Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging’’ (https://www.fda.gov/ Radiation-EmittingProducts/ RadiationSafety/ RadiationDoseReduction/ ucm2007191.htm); and on March 30 and 31, 2010 (75 FR 8375, February 24, 2010), the Agency held a public meeting entitled ‘‘Device Improvements to Reduce Unnecessary Radiation Exposure from Medical Imaging’’ (https://www.federalregister.gov/ documents/2010/02/24/2010-3674/ device-improvements-to-reduceunnecessary-radiation-exposure-frommedical-imaging-public-meeting). At the meeting, FDA sought advice on ‘‘steps PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 56249 that manufacturers of computerized tomography (CT) and fluoroscopic devices could take to reduce unnecessary radiation exposure through improved product design, enhanced labeling, or improved instructions and training for equipment use and quality assurance at medical imaging facilities.’’ The Agency asked whether manufacturers should incorporate special provisions for pediatric patients, particularly with regard to hardware and software features. Recommendations received by FDA, which apply to all general-use x-ray imaging modalities, included making available pediatric protocols and control settings, targeted instructions, and educational materials emphasizing pediatric dose reduction, quality assurance tools for facilities emphasizing radiation dose management, and dose information applicable to pediatric patients. Many of the recommendations from pediatric experts focused on expanding the flexibility or range of features already available on x-ray imaging devices, which may also improve adult imaging for nonstandard applications. In the Federal Register of May 10, 2012 (77 FR 27461), the Agency announced the issuance of the draft guidance entitled ‘‘Pediatric Information for X-ray Imaging Device Premarket Notifications’’ and interested persons were invited to comment by September 7, 2012. On July 16, 2012 (77 FR 27463, May 10, 2012), the Agency held a public meeting entitled ‘‘Device Improvements for Pediatric X-ray Imaging’’ (https:// www.regulations.gov/document? D=FDA-2012-N-0385-0002) where FDA also solicited public feedback on the draft of this guidance. FDA has considered the comments received and has incorporated changes suggested by the comments, as appropriate. In addition, FDA requested help in identifying issues relevant to radiation safety in pediatric x-ray imaging that might benefit from standards development or further research at this workshop. FDA requested specific comments on technical device design and pediatric safety questions. Since the 2012 meeting, many recommended device design improvements have been incorporated into FDA-recognized consensus standards, and others are under consideration for future revisions of such standards. In 2014, the Agency issued a revised general pediatric guidance entitled ‘‘Premarket Assessment of Pediatric Medical Devices.’’ The guidance, which applies to all devices, defines pediatric subpopulations and the general information that should be provided for E:\FR\FM\28NON1.SGM 28NON1 56250 Federal Register / Vol. 82, No. 227 / Tuesday, November 28, 2017 / Notices different types of premarket submissions for devices intended for use in pediatric populations. 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 pediatric information for x-ray imaging device 510(k)s. 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. This guidance is not subject to Executive Order 12866. ethrower on DSK3G9T082PROD with NOTICES 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. This guidance document is also available at https://www.regulations.gov. Persons unable to download an electronic copy of ‘‘Pediatric Information for X-ray Imaging Device Premarket Notifications’’ may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number 1771 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 and guidance documents. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501– 3520). The collections of information in 21 CFR part 807, subpart E have been approved under OMB control number 0910–0120; the collections of information in 21 CFR part 801 have been approved under OMB control number 0910–0485; and the collections of information in 21 CFR parts 1002, 1010, 1020, 1030, 1040, and 1050 have been approved under OMB control number 0910–0025. The collections of information in the guidance document ‘‘Requests for Feedback on Medical Device Submissions: The PreSubmission Program and Meetings with Food and Drug Administration Staff’’ have been approved under OMB control number 0910–0756. In addition, FDA concludes that the Indications for Use VerDate Sep<11>2014 19:51 Nov 27, 2017 Jkt 244001 warning label does not constitute a ‘‘collection of information’’ under the PRA. Rather, the labeling statements are ‘‘public disclosure(s) of information originally supplied by the Federal government to the recipient for the purpose of disclosure to the public.’’ (5 CFR 1320.3(c)(2).) Dated: November 21, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017–25632 Filed 11–27–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA–2016–E–1195 and FDA– 2016–E–1534] Determination of Regulatory Review Period for Purposes of Patent Extension; Senza Spinal Cord Stimulation System AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for Senza Spinal Cord Stimulation System and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device. DATES: Anyone with knowledge that any of the dates as published (in the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by January 29, 2018. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by May 29, 2018. See ‘‘Petitions’’ in the SUPPLEMENTARY INFORMATION section for more information. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before January 29, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of January 29, 2018. Comments received by mail/hand SUMMARY: PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. 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): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, 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 Nos. FDA– 2016–E–1195 and FDA–2016–E–1534 for Determination of Regulatory Review Period for Purposes of Patent Extension; SENZA SPINAL CORD STIMULATION SYSTEM. Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. E:\FR\FM\28NON1.SGM 28NON1

Agencies

[Federal Register Volume 82, Number 227 (Tuesday, November 28, 2017)]
[Notices]
[Pages 56248-56250]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-25632]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0384]

Pediatric Information for X-Ray Imaging Device Premarket
Notifications; 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 or Agency) is announcing
the availability of the guidance entitled ``Pediatric Information for
X-ray Imaging Device Premarket Notifications.'' This guidance document
outlines FDA's current thinking on information that should be provided
in premarket notification submissions for x-ray imaging devices that
are indicated for pediatric populations or general use x-ray imaging
devices for which considerable pediatric application is anticipated.
FDA intends for this guidance to minimize uncertainty during the
premarket review process of premarket notification submissions for x-
ray imaging devices for pediatric use to encourage the inclusion of
pediatric indications for use for x-ray imaging device premarket
notification submissions and to provide recommendations on information
to support such indications. Both new devices and modifications of
existing x-ray imaging devices that require submission of a new
premarket notification are included within the scope of this guidance
document, regardless of whether the device is a complete x-ray imaging
system, a component part of an x-ray imaging device, or an accessory
(e.g., detectors and software).

DATES: The announcement of the guidance is published in the Federal
Register on November 28, 2017.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time 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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, 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-

[[Page 56249]]

2012-D-0384 for ``Pediatric Information for X-ray Imaging Device
Premarket Notifications.'' 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 Dockets
Management Staff 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 Dockets Management Staff. 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.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
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
``Pediatric Information for X-ray Imaging Device Premarket
Notifications'' 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: Laurel Burk, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4268, Silver Spring, MD 20993-0002, 301-796-5933.

SUPPLEMENTARY INFORMATION:

I. Background

This guidance document outlines the current thinking of FDA
regarding information that should be provided in premarket notification
submissions (510(k)s) and device labeling for x-ray imaging devices
that are indicated for pediatric populations or general use x-ray
imaging devices for which considerable pediatric application is
anticipated. General use x-ray imaging devices typically neither
include nor exclude specific populations in the indications for use and
may be expected to be used in any population. Because a large
percentage of the hundreds of millions of x-ray examinations performed
annually in the United States are exams of pediatric patients, FDA
expects that most general use x-ray imaging devices will be used for a
considerable quantity of pediatric examinations unless a device's
design precludes use in smaller sized patients. This guidance is
intended to enhance clarity regarding the premarket review process of
510(k)s for x-ray imaging devices, to encourage the inclusion of
pediatric indications for use for x-ray imaging device 510(k)s, and to
provide recommendations regarding labeling, including the instructions
for use.
In February 2010, FDA launched an ``Initiative to Reduce
Unnecessary Radiation Exposure from Medical Imaging'' (https://www.fda.gov/Radiation-EmittingProducts/RadiationSafety/RadiationDoseReduction/ucm2007191.htm); and on March 30 and 31, 2010
(75 FR 8375, February 24, 2010), the Agency held a public meeting
entitled ``Device Improvements to Reduce Unnecessary Radiation Exposure
from Medical Imaging'' (https://www.federalregister.gov/documents/2010/02/24/2010-3674/device-improvements-to-reduce-unnecessary-radiation-exposure-from-medical-imaging-public-meeting). At the meeting, FDA
sought advice on ``steps that manufacturers of computerized tomography
(CT) and fluoroscopic devices could take to reduce unnecessary
radiation exposure through improved product design, enhanced labeling,
or improved instructions and training for equipment use and quality
assurance at medical imaging facilities.'' The Agency asked whether
manufacturers should incorporate special provisions for pediatric
patients, particularly with regard to hardware and software features.
Recommendations received by FDA, which apply to all general-use x-ray
imaging modalities, included making available pediatric protocols and
control settings, targeted instructions, and educational materials
emphasizing pediatric dose reduction, quality assurance tools for
facilities emphasizing radiation dose management, and dose information
applicable to pediatric patients. Many of the recommendations from
pediatric experts focused on expanding the flexibility or range of
features already available on x-ray imaging devices, which may also
improve adult imaging for nonstandard applications.
In the Federal Register of May 10, 2012 (77 FR 27461), the Agency
announced the issuance of the draft guidance entitled ``Pediatric
Information for X-ray Imaging Device Premarket Notifications'' and
interested persons were invited to comment by September 7, 2012. On
July 16, 2012 (77 FR 27463, May 10, 2012), the Agency held a public
meeting entitled ``Device Improvements for Pediatric X-ray Imaging''
(https://www.regulations.gov/document?D=FDA-2012-N-0385-0002) where FDA
also solicited public feedback on the draft of this guidance. FDA has
considered the comments received and has incorporated changes suggested
by the comments, as appropriate. In addition, FDA requested help in
identifying issues relevant to radiation safety in pediatric x-ray
imaging that might benefit from standards development or further
research at this workshop. FDA requested specific comments on technical
device design and pediatric safety questions. Since the 2012 meeting,
many recommended device design improvements have been incorporated into
FDA-recognized consensus standards, and others are under consideration
for future revisions of such standards.
In 2014, the Agency issued a revised general pediatric guidance
entitled ``Premarket Assessment of Pediatric Medical Devices.'' The
guidance, which applies to all devices, defines pediatric
subpopulations and the general information that should be provided for

[[Page 56250]]

different types of premarket submissions for devices intended for use
in pediatric populations.

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 pediatric information for x-ray imaging
device 510(k)s. 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. This guidance is not subject to Executive Order 12866.

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. This
guidance document is also available at https://www.regulations.gov.
Persons unable to download an electronic copy of ``Pediatric
Information for X-ray Imaging Device Premarket Notifications'' may send
an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic
copy of the document. Please use the document number 1771 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 and guidance documents. These
collections of information are subject to review by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995
(PRA) (44 U.S.C. 3501-3520). The collections of information in 21 CFR
part 807, subpart E have been approved under OMB control number 0910-
0120; the collections of information in 21 CFR part 801 have been
approved under OMB control number 0910-0485; and the collections of
information in 21 CFR parts 1002, 1010, 1020, 1030, 1040, and 1050 have
been approved under OMB control number 0910-0025. 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. In addition, FDA concludes that the Indications for
Use warning label does not constitute a ``collection of information''
under the PRA. Rather, the labeling statements are ``public
disclosure(s) of information originally supplied by the Federal
government to the recipient for the purpose of disclosure to the
public.'' (5 CFR 1320.3(c)(2).)

Dated: November 21, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-25632 Filed 11-27-17; 8:45 am]
BILLING CODE 4164-01-P

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