Medical X-Ray Imaging Devices Conformance With International Electrotechnical Commission Standards; Draft Guidance for Industry and Food and Drug Administration Staff; Availability, 51201-51204 [2016-18300]
Download as PDF
<![CDATA[
51201
Federal Register / Vol. 81, No. 149 / Wednesday, August 3, 2016 / Notices
that half of the control practices (25/50)
administer CG–CAHPS data, as this
percentage is unknown; while 90% of
the participating current and past
CAHPS practices (90/100) will submit
CAHPS data, yielding 115 submissions
of CAHPS patient experience data files.
As indicated below, the annual total
burden is estimated to be 179 hours.
EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent
Hours per
response
Total burden
hours
Data collection task
Number of respondents
Office Manager Questions .........................................
Physician Interview ....................................................
PCMH–A Assessment Tool .......................................
1 .........................................
1 .........................................
1 (same person as above)
5/60
40/60
15/60
12.5
100
37.5
CAHPS Patient Experience Data Files .....................
150 ...................................
150 ...................................
150 (same physicians as
above).
115 ...................................
1 per practice .....................
15/60
28.75
Total ....................................................................
415 ...................................
1 .........................................
75/60
178.75
+ The same respondent completes the Physician Interview and PCMH–A Assessment Tool and submits the CAHPS Patient Experience Data
Files.
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of
requests
Data collection task
Office Manager Questions ...............................................................................
Physician Interview ..........................................................................................
PCMH–A Assessment Tool .............................................................................
CAHPS Patient Experience Data Files ............................................................
Total ..........................................................................................................
150
150
150
115
300
Average
hourly wage
rate *
Total burden
hours
a $57.44
12.5
100
37.5
28.75
178.75
b 97.33
b 97.33
b 97.33
55.48
Total cost
burden
$718.00
9,733.00
3,649.88
2,798.24
16,899.12
+ The same respondent completes the Physician Interview and PCMH–A Assessment Tool and submits the CAHPS Patient Experience Data
Files.
* Occupational Employment Statistics, May 2015 National Occupational Employment and Wage Estimates United States, U.S. Department of
Labor, Bureau of Labor Statistics. https://www.bls.gov/oes/current/oes_nat.htm.
a Based on the mean wages for General and Operations Managers, 11–1021 within Healthcare Support Occupations, the occupational group
most likely tasked with completing the Office Manager Questions.
b Based on the mean wages for Physicians and Surgeons, 29–1060, the occupational group most likely tasked with completing the Physician
Interview, PCMH–A Assessment Tool, and submitting the CAHPS Patient Experience Data Files.
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Request for Comments
In accordance with the Paperwork
Reduction Act, comments on AHRQ’s
information collection are requested
with regard to any of the following: (a)
Whether the proposed collection of
information is necessary for the proper
performance of AHRQ health care
research and health care information
dissemination functions, including
whether the information will have
practical utility; (b) the accuracy of
AHRQ’s estimate of burden (including
hours and costs) of the proposed
collection(s) of information; (c) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(d) ways to minimize the burden of the
collection of information upon the
respondents, including the use of
automated collection techniques or
other forms of information technology.
Comments submitted in response to
this notice will be summarized and
included in the Agency’s subsequent
request for OMB approval of the
proposed information collection. All
VerDate Sep<11>2014
18:21 Aug 02, 2016
Jkt 238001
comments will become a matter of
public record.
Sharon B. Arnold,
Deputy Director.
[FR Doc. 2016–18392 Filed 8–2–16; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–D–2049]
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:
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
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
ADDRESSES:
You may submit comments
as follows:
Notice of availability.
SUMMARY:
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.
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
E:\FR\FM\03AUN1.SGM
03AUN1
51202
Federal Register / Vol. 81, No. 149 / Wednesday, August 3, 2016 / Notices
asabaliauskas on DSK3SPTVN1PROD with NOTICES
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): 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
https://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
VerDate Sep<11>2014
18:21 Aug 02, 2016
Jkt 238001
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on https://
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: https://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 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 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 selfaddressed 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
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
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 https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
Guidance documents are also available
at https://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 CDRHGuidance@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
E:\FR\FM\03AUN1.SGM
03AUN1
51203
Federal Register / Vol. 81, No. 149 / Wednesday, August 3, 2016 / Notices
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:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1,2,3
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Product reports—
1002.10(a)–(k).
3626—Diagnostic x-ray .....................
3627—CT x-ray .................................
3639—Cabinet x-ray ..........................
3632—Laser ......................................
3640—Laser light show .....................
3630—Sunlamp .................................
3646—Mercury vapor lamp ...............
3644—Ultrasonic therapy ..................
3659—TV ...........................................
3660—Microwave oven .....................
3801—UV lamps ...............................
............................................................
1,466
1.1
1,613
24
38,712
966
1.5
1,449
0.5
725
3629—General abbreviated report ....
3661—X-ray tables, etc. ....................
3662—Cephalometric device ............
3663—Microwave products (nonoven).
73
2
146
5
730
VerDate Sep<11>2014
18:21 Aug 02, 2016
Jkt 238001
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
Total annual
responses
Average
burden per
response
FDA form
Product safety or
testing
changes—
1002.11(a)–(b).
Abbreviated reports—1002.12.
Number of
respondents
Number of
responses per
respondent
Activity/21 CFR
section
E:\FR\FM\03AUN1.SGM
03AUN1
Total hours
51204
Federal Register / Vol. 81, No. 149 / Wednesday, August 3, 2016 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1,2,3—Continued
Activity/21 CFR
section
FDA form
Number of
respondents
Annual reports—
1002.13(a)–(b).
3628—General ..................................
3634—TV ...........................................
3638—Diagnostic x-ray .....................
3641—Cabinet x-ray ..........................
3643—Microwave oven .....................
3636—Laser ......................................
3631—Sunlamp .................................
3647—Mercury vapor lamp ...............
3645—Ultrasonic therapy ..................
Number of
responses per
respondent
1,466
Total annual
responses
1
1,466
Average
burden per
response
18
Total hours
26,388
1 This table includes the recalculated burden estimate only for information collections (ICs) that are applicable to this draft guidance. It does not
include all ICs approved under OMB control number 0910–0025. The draft guidance, if finalized, would be a reduction to the burden estimate for
these ICs, except that the Abbreviated reports IC increases. We have described the overall reduction in the text of this document. However, to
avoid confusion, we have not included a total burden estimate in this table because such a total would include ICs that are not applicable to the
draft guidance.
2 There are no capital costs or operating and maintenance costs associated with this collection of information.
3 Totals may not sum due to rounding.
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.
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by September
2, 2016.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0131. Also
include the FDA docket number found
in brackets in the heading of this
document.
Dated: July 28, 2016.
Leslie Kux,
Associate Commissioner for Policy.
FOR FURTHER INFORMATION CONTACT:
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, Three White
Flint North 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
[FR Doc. 2016–18300 Filed 8–2–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Agreement for Shipment of Devices for
Sterilization—21 CFR 801.150—OMB
Control Number 0910–0131—Extension
[Docket No. FDA–2013–N–0375]
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Agreement for
Shipment of Devices for Sterilization
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
SUMMARY:
VerDate Sep<11>2014
18:21 Aug 02, 2016
Jkt 238001
Under sections 501(c) and 502(a) of
the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (21 U.S.C. 351(c)
and 352(a)), nonsterile devices that are
labeled as sterile but are in interstate
transit to a facility to be sterilized are
adulterated and misbranded. FDA
regulations in § 801.150(e) (21 CFR
801.150(e)) establish a control
mechanism by which firms may
manufacture and label medical devices
as sterile at one establishment and ship
the devices in interstate commerce for
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
sterilization at another establishment, a
practice that facilitates the processing of
devices and is economically necessary
for some firms.
Under § 801.150(e)(1), manufacturers
and sterilizers may sign an agreement
containing the following: (1)
Instructions for maintaining
accountability of the number of units in
each shipment, (2) acknowledgment that
the devices that are nonsterile are being
shipped for further processing, and (3)
specifications for sterilization
processing. This agreement allows the
manufacturer to ship misbranded
products to be sterilized without
initiating regulatory action and provides
FDA with a means to protect consumers
from use of nonsterile products. During
routine plant inspections, FDA normally
reviews agreements that must be kept
for 2 years after final shipment or
delivery of devices (§ 801.150(a)(2)).
The respondents to this collection of
information are device manufacturers
and contract sterilizers. FDA’s estimate
of the reporting burden is based on data
obtained from industry over the past
several years. It is estimated that each of
the firms subject to this requirement
prepares an average of 20 written
agreements each year. This estimate
varies greatly, from 1 to 100, because
some firms provide sterilization services
on a part-time basis for only one
customer, while others are large
facilities with many customers. The
average time required to prepare each
written agreement is estimated to be 4
hours. This estimate varies depending
on whether the agreement is the initial
agreement or an annual renewal, on the
format each firm elects to use, and on
the length of time required to reach
agreement. The estimate applies only to
those portions of the written agreement
that pertain to the requirements
E:\FR\FM\03AUN1.SGM
03AUN1
]]>Agencies
[Federal Register Volume 81, Number 149 (Wednesday, August 3, 2016)]
[Notices]
[Pages 51201-51204]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-18300]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-D-2049]
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: https://www.regulations.gov.
Follow the instructions for submitting comments.
[[Page 51202]]
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): 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 https://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 https://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: https://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 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 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 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available at
https://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
[[Page 51203]]
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:
Table 1--Estimated Annual Reporting Burden \1,2,3\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average
Activity/21 CFR section FDA form Number of responses per Total annual burden per Total hours
respondents respondent responses response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Product reports--1002.10(a)-(k)........ 3626--Diagnostic x-ray......... 1,466 1.1 1,613 24 38,712
3627--CT x-ray.................
3639--Cabinet x-ray............
3632--Laser.................... ..............
3640--Laser light show......... ..............
3630--Sunlamp.................. ..............
3646--Mercury vapor lamp....... ..............
3644--Ultrasonic therapy....... ..............
3659--TV....................... ..............
3660--Microwave oven........... ..............
3801--UV lamps................. ..............
Product safety or testing changes-- ............................... 966 1.5 1,449 0.5 725
1002.11(a)-(b).
Abbreviated reports--1002.12........... 3629--General abbreviated 73 2 146 5 730
report.
3661--X-ray tables, etc........
3662--Cephalometric device..... ..............
3663--Microwave products (non- ..............
oven).
[[Page 51204]]
Annual reports--1002.13(a)-(b)......... 3628--General.................. 1,466 1 1,466 18 26,388
3634--TV.......................
3638--Diagnostic x-ray.........
3641--Cabinet x-ray............ ..............
3643--Microwave oven........... ..............
3636--Laser.................... ..............
3631--Sunlamp.................. ..............
3647--Mercury vapor lamp....... ..............
3645--Ultrasonic therapy....... ..............
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ This table includes the recalculated burden estimate only for information collections (ICs) that are applicable to this draft guidance. It does not
include all ICs approved under OMB control number 0910-0025. The draft guidance, if finalized, would be a reduction to the burden estimate for these
ICs, except that the Abbreviated reports IC increases. We have described the overall reduction in the text of this document. However, to avoid
confusion, we have not included a total burden estimate in this table because such a total would include ICs that are not applicable to the draft
guidance.
\2\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\3\ Totals may not sum due to rounding.
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.
Dated: July 28, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-18300 Filed 8-2-16; 8:45 am]
BILLING CODE 4164-01-P
