Medical X-Ray Imaging Devices Conformance With International Electrotechnical Commission Standards; Draft Guidance for Industry and Food and Drug Administration Staff; Availability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The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled “Medical X-Ray Imaging Devices Conformance With IEC Standards.” This draft guidance describes FDA's policy regarding the regulation of medical x-ray imaging equipment that are subject to requirements in the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and FDA's regulations that apply to medical devices and electronic products. The draft guidance also provides recommendations to industry on how to comply with the applicable requirements. This draft guidance is not final nor is it in effect at this time.

DATES:

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by November 1, 2016.

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-2016-D-2049 for “Medical X-Ray Imaging Devices Conformance With IEC Standards.” 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 draft guidance document entitled “Medical X-Ray Imaging Devices Conformance With IEC Standards” 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:

Robert Sauer, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5628, Silver Spring, MD 20993-0002, 301-796-3580.

SUPPLEMENTARY INFORMATION:

I. Background

This draft guidance describes FDA's policy regarding the regulation of medical x-ray imaging equipment that are subject to requirements in the FD&C Act and FDA's regulations that apply to medical devices and electronic products. In the draft guidance, FDA is seeking to harmonize performance standards prescribed under section 534 of subchapter C (Electronic Product Radiation Control (EPRC)) of the FD&C Act (21 U.S.C. 360kk) with International Electrotechnical Commission (IEC) standards, where appropriate, to help to ensure streamlined regulatory review of submissions for these products. The draft guidance also provides recommendations to industry on how to comply with the applicable requirements. FDA believes industry conformance to certain IEC standards would provide the same level of or improved protection of the public health and safety from electronic radiation as certain EPRC regulatory standards. FDA also believes conformance to certain IEC standards would be sufficient to meet the 510(k) premarket notification requirement for certain devices. FDA review of related radiological health and safety data in premarket submissions, as opposed to EPRC product reports, would maintain or improve device safety while consolidating the information manufacturers submit to FDA.

II. Significance of Guidance

This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on “Medical X-Ray Imaging Devices Conformance With IEC Standards.” 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 draft guidance may do so by downloading an electronic copy from the Internet. A search capability for all CDRH 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 “Medical X-Ray Imaging Devices Conformance With IEC Standards” may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number 1400014 to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed revision of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

Reporting and Recordkeeping for Electronic Products—General Requirements—21 CFR parts 1002 through 1050—OMB Control Number 0910-0025—Revision

The draft guidance describes FDA's policy regarding the regulation of medical x-ray imaging equipment that are subject to FDA's regulations that apply to medical devices and electronic products. FDA believes industry conformance to certain IEC standards would be sufficient to meet the 510(k) premarket notification requirement for certain of these devices. FDA review of related radiological health and safety data in premarket submissions, as opposed to EPRC product reports, would maintain or improve device safety while consolidating the information manufacturers submit to FDA. Currently, information regarding the IEC standards is submitted as part of the premarket notification (approved under OMB control number 0910-0120). Under the draft guidance, if finalized, respondents may choose to submit declarations of conformity with certain IEC standards—in either a 510(k) or if no 510(k) is submitted in an Abbreviated Report under 21 CFR 1002.12(e)—instead of submitting EPRC reports for certain devices in the circumstances described in the draft guidance.

Based on an analysis of recent submissions from Fiscal Year (FY) 2015, approximately 93 percent of manufacturers of Class II medical x-ray imaging devices, including CT, fluoroscopy, and stationary x-ray systems, claimed conformance to an applicable IEC standard. Accordingly, we believe that the majority of manufacturers of Class II medical x-ray imaging systems would choose to continue to submit declarations of conformity to these IEC standards and not submit EPRC product reports, supplemental reports, and annual reports under the guidance. The other 7 percent of manufacturers of Class II medical x-ray imaging devices and likely a subset of these 93 percent may choose to submit product reports, supplemental reports, and annual reports.

In FY 2015, there were 22 Class II product reports and 13 Class I product reports for x-ray imaging devices submitted to FDA. Therefore, we expect a reduction of 34 respondents to the estimated burden for the product reports, supplemental reports, and annual report information collections in table 1 of this document. Because 13 of these x-ray imaging devices are 510(k)-exempt, Class I devices, we would expect an increase of 13 respondents to the estimated burden for the information collection related to Abbreviated Reports in table 1 of this document (as these manufacturers would be submitting their declarations of conformity in these reports), which corresponds to an expected reduction of 13 respondents to the estimated burden for the product reports, supplemental reports, and annual reports information collections in table 1 of this document. This equals an overall reduction of 1,395 hours in OMB control number 0910-0025.

FDA estimates the burden of this collection of information as follows:

The draft guidance also refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by OMB under the PRA. 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; the collections of information in 21 CFR part 820 have been approved under OMB control number 0910-0073. The collections of information in 21 CFR parts 1002 through 1050 are approved under OMB control number 0910-0025.