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 ( printed 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 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).)