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AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice of availability.
SUMMARY:
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled “Clarification of Radiation Control Regulations for Manufacturers of Diagnostic X-Ray Equipment.” This guidance provides clarification to industry and FDA staff of the Federal regulations that relate to diagnostic x-ray equipment. These regulations pertain to the recordkeeping, reporting, manufacturing, importing, and installation of an “electronic product” as defined in FDA regulations. This guidance supersedes FDA's 1989 guidance entitled “Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment.”
DATES:
The announcement of the guidance is published in the Federal Register on September 30, 2024.
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-2018-D-4115 for “Clarification of Radiation Control Regulations for Manufacturers of Diagnostic X-Ray Equipment.” 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, 240-402-7500.
- 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.govinfo.gov/content/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, 240-402-7500.
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 “Clarification of Radiation Control Regulations for Manufacturers of Diagnostic X-Ray Equipment” to the Office of Policy, 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. 3668, Silver Spring, MD 20993-0002, 301-796-5933.
SUPPLEMENTARY INFORMATION:
I. Background
This guidance provides clarification to industry and FDA staff of the Federal regulations that relate to diagnostic x-ray equipment. Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), diagnostic x-ray systems are considered to be both medical devices, under section 201(h) of the FD&C Act (21 U.S.C. 321(h)), and electronic products, under section 531 of the FD&C Act (21 U.S.C. 360hh). As such, they are subject to the provisions of the FD&C Act that apply to medical devices ( e.g., sections 510 and 520 of the FD&C Act (21 U.S.C. 360 and 360j)), and their implementing regulations, as well as the provisions of the FD&C Act (sections 531 through 542 of the FD&C Act (21 U.S.C. 360hh through 360ss)) that apply to electronic products, known as the Electronic Product Radiation Control (EPRC) provisions and their implementing regulations. FDA's EPRC regulations pertain to the recordkeeping, reporting, manufacturing, importing, and installation of an “electronic product” as defined under 21 CFR 1000.3(j). This guidance supersedes FDA's guidance entitled “Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment” (HHS Publication FDA 89-8221 issued in March 1989).
A notice of availability of the draft guidance appeared in the Federal Register of December 17, 2018 (83 FR 64584). FDA considered the comments received and revised the guidance as appropriate. Revisions include the addition of new questions and updates to existing questions in the sections related to alternate test methods to demonstrate compliance with performance standards, as well as the applicability of performance standards to x-ray based image-guidance used with radiation therapy devices, certification and associated labeling of certifiable components, assembly instructions, accidental radiation occurrence, and defects. In addition, FDA revised other questions and responses throughout the guidance to provide additional clarification and for editorial accuracy. Questions and responses related to certain reports that are no longer required were also removed (see “Radiological Health Regulations; Amendments to Records and Reports for Radiation Emitting Electronic Products; Amendments to Performance Standards for Diagnostic X-ray, Laser, and Ultrasonic Products” published in the Federal Register of January 20, 2023 (88 FR 3638)).
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 “Clarification of Radiation Control Regulations for Manufacturers of Diagnostic X-Ray Equipment.” 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.
II. 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/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also available at https://www.regulations.gov or https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Persons unable to download an electronic copy of “Clarification of Radiation Control Regulations for Manufacturers of Diagnostic X-Ray Equipment” may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number GUI01500029 and complete title to identify the guidance you are requesting.
III. Paperwork Reduction Act of 1995
While this guidance contains no new collection of information, it does refer to previously approved FDA collections of information. The previously approved 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. 3501-3521). The collections of information in the following FDA table have been approved by OMB:
| 21 CFR Part or FDA Form | Topic | OMB Control No. |
|---|---|---|
| 1002, 1005, 1010, 1020, 1030, 1040, and 1050; form FDA 2579 and form FDA 2877 | Reporting and Recordkeeping for Electronic Products—General Requirements | 0910-0025 |
| 800, 801, and 809 | Labeling | 0910-0485 |
| 812 | Investigational Device Exemption | 0910-0078 |
| “Allegations of Regulatory Misconduct” form | Voluntary Allegations of Regulatory Misconduct | 0910-0769 |