82 FR 56248 - Pediatric Information for X-Ray Imaging Device Premarket Notifications; Guidance for Industry and Food and Drug Administration Staff; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 227 (November 28, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 227 (November 28, 2017)
| Page Range | 56248-56250 | |
| FR Document | 2017-25632 |
[Federal Register Volume 82, Number 227 (Tuesday, November 28, 2017)] [Notices] [Pages 56248-56250] From the Federal Register Online [www.thefederalregister.org] [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.thefederalregister.org/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 http://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 [email protected] 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
![56248 Federal Register / Vol. 82, No. 227 / Tuesday, November 28, 2017 / Notices
received a patent term restoration during the regulatory review period. To support such indications. Both new
application for YONDELIS (U.S. Patent meet its burden, the petition must devices and modifications of existing x-
No. 7,420,051) from Pharma Mar, S.A., comply with all the requirements of ray imaging devices that require
and the USPTO requested FDA’s § 60.30, including but not limited to: submission of a new premarket
assistance in determining this patent’s Must be timely (see DATES), must be notification are included within the
eligibility for patent term restoration. In filed in accordance with § 10.20, must scope of this guidance document,
a letter dated August 25, 2016, FDA contain sufficient facts to merit an FDA regardless of whether the device is a
advised the USPTO that this human investigation, and must certify that a complete x-ray imaging system, a
drug product had undergone a true and complete copy of the petition component part of an x-ray imaging
regulatory review period and that the has been served upon the patent device, or an accessory (e.g., detectors
approval of YONDELIS represented the applicant. (See H. Rept. 857, part 1, 98th and software).
first permitted commercial marketing or Cong., 2d sess., pp. 41–42, 1984.) DATES: The announcement of the
use of the product. Thereafter, the Petitions should be in the format guidance is published in the Federal
USPTO requested that FDA determine specified in 21 CFR 10.30. Register on November 28, 2017.
the product’s regulatory review period. Submit petitions electronically to ADDRESSES: You may submit either
II. Determination of Regulatory Review https://www.regulations.gov at Docket electronic or written comments on
Period No. FDA–2013–S–0610. Submit written Agency guidances at any time as
petitions (two copies are required) to the follows:
FDA has determined that the Dockets Management Staff (HFA–305),
applicable regulatory review period for Food and Drug Administration, 5630 Electronic Submissions
YONDELIS is 7,107 days. Of this time, Fishers Lane, Rm. 1061, Rockville, MD
6,773 days occurred during the testing Submit electronic comments in the
20852. following way:
phase of the regulatory review period,
while 334 days occurred during the Dated: November 22, 2017. • Federal eRulemaking Portal:
approval phase. These periods of time Leslie Kux, https://www.regulations.gov. Follow the
were derived from the following dates: Associate Commissioner for Policy. instructions for submitting comments.
1. The date an exemption under [FR Doc. 2017–25683 Filed 11–27–17; 8:45 am] Comments submitted electronically,
section 505(i) of the Federal Food, Drug, BILLING CODE 4164–01–P
including attachments, to https://
and Cosmetic Act (the FD&C Act) (21 www.regulations.gov will be posted to
U.S.C. 355(i)) became effective: May 10, the docket unchanged. Because your
1996. FDA has verified the applicant’s DEPARTMENT OF HEALTH AND comment will be made public, you are
claim that the date the investigational HUMAN SERVICES solely responsible for ensuring that your
new drug application became effective comment does not include any
was on May 10, 1996. Food and Drug Administration confidential information that you or a
2. The date the application was third party may not wish to be posted,
[Docket No. FDA–2012–D–0384]
initially submitted with respect to the such as medical information, your or
human drug product under section Pediatric Information for X-Ray anyone else’s Social Security number, or
505(b) of the FD&C Act: November 24, Imaging Device Premarket confidential business information, such
2014. FDA has verified the applicant’s Notifications; Guidance for Industry as a manufacturing process. Please note
claim that the new drug application and Food and Drug Administration that if you include your name, contact
(NDA) for YONDELIS (NDA 207953) Staff; Availability information, or other information that
was initially submitted on November identifies you in the body of your
24, 2014. AGENCY: Food and Drug Administration, comments, that information will be
3. The date the application was HHS. posted on https://www.regulations.gov.
approved: October 23, 2015. FDA has ACTION: Notice of availability. • If you want to submit a comment
verified the applicant’s claim that NDA with confidential information that you
207953 was approved on October 23, SUMMARY: The Food and Drug do not wish to be made available to the
2015. Administration (FDA or Agency) is public, submit the comment as a
This determination of the regulatory announcing the availability of the written/paper submission and in the
review period establishes the maximum guidance entitled ‘‘Pediatric Information manner detailed (see ‘‘Written/Paper
potential length of a patent extension. for X-ray Imaging Device Premarket Submissions’’ and ‘‘Instructions’’).
However, the USPTO applies several Notifications.’’ This guidance document
outlines FDA’s current thinking on Written/Paper Submissions
statutory limitations in its calculations
of the actual period for patent extension. information that should be provided in Submit written/paper submissions as
In its application for patent extension, premarket notification submissions for follows:
this applicant seeks 1,471 days of patent x-ray imaging devices that are indicated • Mail/Hand delivery/Courier (for
term extension. for pediatric populations or general use written/paper submissions): Dockets
x-ray imaging devices for which Management Staff (HFA–305), Food and
III. Petitions considerable pediatric application is Drug Administration, 5630 Fishers
Anyone with knowledge that any of anticipated. FDA intends for this Lane, Rm. 1061, Rockville, MD 20852.
the dates as published are incorrect may guidance to minimize uncertainty • For written/paper comments
submit either electronic or written during the premarket review process of submitted to the Dockets Management
ethrower on DSK3G9T082PROD with NOTICES
comments and, under 21 CFR 60.24, ask premarket notification submissions for Staff, FDA will post your comment, as
for a redetermination (see DATES). x-ray imaging devices for pediatric use well as any attachments, except for
Furthermore, as specified in § 60.30 (21 to encourage the inclusion of pediatric information submitted, marked and
CFR 60.30), any interested person may indications for use for x-ray imaging identified, as confidential, if submitted
petition FDA for a determination device premarket notification as detailed in ‘‘Instructions.’’
regarding whether the applicant for submissions and to provide Instructions: All submissions received
extension acted with due diligence recommendations on information to must include the Docket No. FDA–
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![56250 Federal Register / Vol. 82, No. 227 / Tuesday, November 28, 2017 / Notices
different types of premarket warning label does not constitute a delivery/courier (for written/paper
submissions for devices intended for ‘‘collection of information’’ under the submissions) will be considered timely
use in pediatric populations. PRA. Rather, the labeling statements are if they are postmarked or the delivery
‘‘public disclosure(s) of information service acceptance receipt is on or
II. Significance of Guidance
originally supplied by the Federal before that date.
This guidance is being issued government to the recipient for the
consistent with FDA’s good guidance Electronic Submissions
purpose of disclosure to the public.’’ (5
practices regulation (21 CFR 10.115). CFR 1320.3(c)(2).) Submit electronic comments in the
The guidance represents the current following way:
Dated: November 21, 2017.
thinking of FDA on pediatric • Federal eRulemaking Portal:
information for x-ray imaging device Leslie Kux,
https://www.regulations.gov. Follow the
510(k)s. It does not establish any rights Associate Commissioner for Policy.
instructions for submitting comments.
for any person and is not binding on [FR Doc. 2017–25632 Filed 11–27–17; 8:45 am]
Comments submitted electronically,
FDA or the public. You can use an BILLING CODE 4164–01–P
including attachments, to https://
alternative approach if it satisfies the www.regulations.gov will be posted to
requirements of the applicable statutes the docket unchanged. Because your
and regulations. This guidance is not DEPARTMENT OF HEALTH AND
comment will be made public, you are
subject to Executive Order 12866. HUMAN SERVICES
solely responsible for ensuring that your
III. Electronic Access Food and Drug Administration comment does not include any
Persons interested in obtaining a copy confidential information that you or a
[Docket Nos. FDA–2016–E–1195 and FDA– third party may not wish to be posted,
of the guidance may do so by 2016–E–1534]
downloading an electronic copy from such as medical information, your or
the internet. A search capability for all anyone else’s Social Security number, or
Determination of Regulatory Review
Center for Devices and Radiological confidential business information, such
Period for Purposes of Patent
Health guidance documents is available as a manufacturing process. Please note
Extension; Senza Spinal Cord
at http://www.fda.gov/MedicalDevices/ that if you include your name, contact
Stimulation System
DeviceRegulationandGuidance/ information, or other information that
GuidanceDocuments/default.htm. This AGENCY: Food and Drug Administration, identifies you in the body of your
guidance document is also available at HHS. comments, that information will be
https://www.regulations.gov. Persons ACTION: Notice. posted on https://www.regulations.gov.
unable to download an electronic copy • If you want to submit a comment
SUMMARY: The Food and Drug with confidential information that you
of ‘‘Pediatric Information for X-ray
Administration (FDA or the Agency) has do not wish to be made available to the
Imaging Device Premarket
determined the regulatory review period public, submit the comment as a
Notifications’’ may send an email
for Senza Spinal Cord Stimulation written/paper submission and in the
request to CDRH-Guidance@fda.hhs.gov
System and is publishing this notice of manner detailed (see ‘‘Written/Paper
to receive an electronic copy of the
that determination as required by law. Submissions’’ and ‘‘Instructions’’).
document. Please use the document
FDA has made the determination
number 1771 to identify the guidance Written/Paper Submissions
because of the submission of
you are requesting.
applications to the Director of the U.S. Submit written/paper submissions as
IV. Paperwork Reduction Act of 1995 Patent and Trademark Office (USPTO), follows:
This guidance refers to previously Department of Commerce, for the • Mail/Hand delivery/Courier (for
approved collections of information extension of a patent which claims that written/paper submissions): Dockets
found in FDA regulations and guidance medical device. Management Staff (HFA–305), Food and
documents. These collections of DATES: Anyone with knowledge that any Drug Administration, 5630 Fishers
information are subject to review by the of the dates as published (in the Lane, Rm. 1061, Rockville, MD 20852.
Office of Management and Budget SUPPLEMENTARY INFORMATION section) are • For written/paper comments
(OMB) under the Paperwork Reduction incorrect may submit either electronic submitted to the Dockets Management
Act of 1995 (PRA) (44 U.S.C. 3501– or written comments and ask for a Staff, FDA will post your comment, as
3520). The collections of information in redetermination by January 29, 2018. well as any attachments, except for
21 CFR part 807, subpart E have been Furthermore, any interested person may information submitted, marked and
approved under OMB control number petition FDA for a determination identified, as confidential, if submitted
0910–0120; the collections of regarding whether the applicant for as detailed in ‘‘Instructions.’’
information in 21 CFR part 801 have extension acted with due diligence Instructions: All submissions received
been approved under OMB control during the regulatory review period by must include the Docket Nos. FDA–
number 0910–0485; and the collections May 29, 2018. See ‘‘Petitions’’ in the 2016–E–1195 and FDA–2016–E–1534
of information in 21 CFR parts 1002, SUPPLEMENTARY INFORMATION section for for Determination of Regulatory Review
1010, 1020, 1030, 1040, and 1050 have more information. Period for Purposes of Patent Extension;
been approved under OMB control ADDRESSES: You may submit comments SENZA SPINAL CORD STIMULATION
number 0910–0025. The collections of as follows. Please note that late, SYSTEM. Received comments, those
information in the guidance document untimely filed comments will not be filed in a timely manner (see
ethrower on DSK3G9T082PROD with NOTICES
‘‘Requests for Feedback on Medical considered. Electronic comments must ADDRESSES), will be placed in the docket
Device Submissions: The Pre- be submitted on or before January 29, and, except for those submitted as
Submission Program and Meetings with 2018. The https://www.regulations.gov ‘‘Confidential Submissions,’’ publicly
Food and Drug Administration Staff’’ electronic filing system will accept viewable at https://www.regulations.gov
have been approved under OMB control comments until midnight Eastern Time or at the Dockets Management Staff
number 0910–0756. In addition, FDA at the end of January 29, 2018. between 9 a.m. and 4 p.m., Monday
concludes that the Indications for Use Comments received by mail/hand through Friday.
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Document Created: 2017-11-28 01:50:55
Document Modified: 2017-11-28 01:50:55
| 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 | The announcement of the guidance is published in the Federal Register on November 28, 2017. | |
| 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. | |
| FR Citation | 82 FR 56248 |
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