Medical Devices; Technical Amendment, 13863-13865 [2018-06308]
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Federal Register / Vol. 83, No. 63 / Monday, April 2, 2018 / Rules and Regulations
promulgate the body system listings
again. Therefore, we have determined
that opportunity for prior comment is
unnecessary, and we are issuing this
regulation as a final rule.
In addition, for the reasons cited
above, we find good cause for
dispensing with the 30-day delay in the
effective date of this final rule. 5 U.S.C.
553(d)(3). We are not making any
substantive changes to the listings in
these body systems. Without an
extension of the expiration dates for
these listings, we will not have the
criteria we need to assess medical
impairments in these two body systems
at step three of the sequential evaluation
processes. We therefore find it is in the
public interest to make this final rule
effective on the publication date.
Executive Order 12866, as
Supplemented by Executive Order
13563
We consulted with the Office of
Management and Budget (OMB) and
determined that this final rule does not
meet the requirements for a significant
regulatory action under Executive Order
12866, as supplemented by Executive
Order 13563. Therefore, OMB did not
review it. We also determined that this
final rule meets the plain language
requirement of Executive Order 12866.
Regulatory Flexibility Act
We certify that this final rule does not
have a significant economic impact on
a substantial number of small entities
because it affects only individuals.
Therefore, a regulatory flexibility
analysis is not required under the
Regulatory Flexibility Act, as amended.
Insurance, Reporting and recordkeeping
requirements, Social Security.
Nancy Berryhill,
Deputy Commissioner for Operations,
performing the duties and functions not
reserved to the Commissioner of Social
Security.
For the reasons set out in the
preamble, we are amending appendix 1
to subpart P of part 404 of chapter III of
title 20 of the Code of Federal
Regulations as set forth below.
PART 404—FEDERAL OLD-AGE,
SURVIVORS AND DISABILITY
INSURANCE (1950–)
Subpart P—[Amended]
1. The authority citation for subpart P
of part 404 continues to read as follows:
■
Authority: Secs. 202, 205(a)–(b) and (d)–
(h), 216(i), 221(a) and (h)-(j), 222(c), 223, 225,
and 702(a)(5) of the Social Security Act (42
U.S.C. 402, 405(a)–(b) and (d)–(h), 416(i),
421(a) and (h)–(j), 422(c), 423, 425, and
902(a)(5)); sec. 211(b), Pub. L. 104–193, 110
Stat. 2105, 2189; sec. 202, Pub. L. 108–203,
118 Stat. 509 (42 U.S.C. 902 note).
2. Amend appendix 1 to subpart P of
part 404 by revising items 3 and 11 of
the introductory text before Part A to
read as follows:
■
Appendix 1 to Subpart P of Part 404—
Listing of Impairments
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3. Special Senses and Speech (2.00 and
102.00): April 24, 2020.
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11. Congenital Disorders That Affect
Multiple Body Systems (10.00 and 110.00):
April 3, 2020.
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[FR Doc. 2018–06671 Filed 3–30–18; 8:45 am]
BILLING CODE 4191–02–P
Paperwork Reduction Act
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
This final rule does not create any
new or affect any existing collections
and, therefore, it does not require
OMB’s approval under the Paperwork
Reduction Act.
Food and Drug Administration
21 CFR Parts 890, 900, 1020, and 1040
(Catalog of Federal Domestic Assistance
Program Nos. 96.001, Social SecurityDisability Insurance; 96.002, Social SecurityRetirement Insurance; 96.004, Social
Security-Survivors Insurance; 96.006,
Supplemental Security Income)
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List of Subjects in 20 CFR Part 404
Administrative practice and
procedure, Blind, Disability benefits,
Old-age, Survivors and Disability
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[Docket No. FDA–2018–N–0011]
Medical Devices; Technical
Amendment
AGENCY:
Food and Drug Administration;
HHS.
Final rule; technical
amendment.
ACTION:
The Food and Drug
Administration (FDA or Agency) is
amending certain medical device
regulations. This action is editorial in
nature to correct typographical errors
SUMMARY:
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13863
and to ensure accuracy and clarity in
the Agency’s regulations.
DATES: This rule is effective April 2,
2018.
FOR FURTHER INFORMATION CONTACT:
Karen Fikes, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5244, Silver Spring,
MD 20993–0002, 301–796–9603.
SUPPLEMENTARY INFORMATION: FDA is
amending our regulations in 21 CFR
parts 890, 900, 1020, and 1040 to correct
typographical errors and to update
addresses, office titles, and wording to
ensure accuracy and clarity in the
Agency’s medical device regulations.
FDA is making nonsubstantive
changes to the following regulations:
1. FDA is revising
§ 890.5525(b)(2)(i)(A) by replacing
‘‘Testing using a drug approved for
iontophoretic delivery, or a solution, if
identified in the labeling, to
demonstrate safe use of the device as
intended’’ with ‘‘Testing using a drug
approved for iontophoretic delivery, or
a solution if identified in the labeling,
to demonstrate safe use of the device as
intended’’.
2. FDA is revising § 900.3(b)(1) by
replacing ‘‘Division of Mammography
Quality and Radiation Programs
(DMQRP), Center for Devices and
Radiology Health (HFZ–240), Food and
Drug Administration, 1350 Piccard Dr.,
Rockville, MD 20850, marked Attn:
Mammography Standards Branch’’ with
‘‘Division of Mammography Quality
Standards, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4445, Silver Spring,
MD 20993, Attn: Program Management
Branch’’.
3. FDA is revising § 900.11(b)(2)(i) by
replacing ‘‘42 U.S.C. 263b(c)(2)’’ with
‘‘42 U.S.C. 263b(c)(4)’’.
4. FDA is revising § 1020.30(c) by
replacing ‘‘Director of the Office of
Communication, Education, and
Radiation Programs of the Center for
Devices and Radiological Health’’ with
‘‘Director, Center for Devices and
Radiological Health’’.
5. FDA is revising § 1040.10(a)(3)(i) by
replacing ‘‘Food and Drug
Administration, Center for Devices and
Radiological Health, Director, Office of
Compliance, 10903 New Hampshire
Ave., Bldg. 66, Rm. 3521, Silver Spring,
MD 20993–0002’’ with ‘‘Director, Center
for Devices and Radiological Health,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Silver
Spring, MD 20993–0002’’.
6. FDA is revising § 1040.10(f)(6)(ii)
by replacing ‘‘Director, Office of
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02APR1
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Federal Register / Vol. 83, No. 63 / Monday, April 2, 2018 / Rules and Regulations
Compliance (HFZ–300), Center for
Devices and Radiological Health’’ with
‘‘Director, Center for Devices and
Radiological Health’’.
7. FDA is revising § 1040.10(g)(10) by
replacing ‘‘Director, Office of
Compliance (HFZ–300), Center for
Devices and Radiological Health’’ with
‘‘Director, Center for Devices and
Radiological Health’’.
8. FDA is revising § 1040.20(d)(3)(iii)
by replacing ‘‘Director, Office of
Communication, Education, and
Radiation Programs 10903 New
Hampshire Ave., Bldg. 66, Rm. 4312,
Silver Spring, MD 20993–0002, Center
for Devices and Radiological Health’’
with ‘‘Director, Center for Devices and
Radiological Health’’.
9. FDA is revising § 1040.20(d)(3)(iv)
by replacing ‘‘manfacturer’’ with
‘‘manufacturer,’’ and replacing
‘‘Director, Office of Compliance (HFZ–
300), Center for Devices and
Radiological Health’’ with ‘‘Director,
Center for Devices and Radiological
Health’’.
§ 890.5525
Iontophoresis device.
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(b) * * *
(2) * * *
(i) * * *
(A) Testing using a drug approved for
iontophoretic delivery, or a solution if
identified in the labeling, to
demonstrate safe use of the device as
intended;
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PART 900—MAMMOGRAPHY
3. The authority citation for part 900
continues to read as follows:
■
Authority: 21 U.S.C. 360i, 360nn, 374(e),
42 U.S.C. 263b.
4. Revise § 900.3(b)(1) to read as
follows:
■
§ 900.3 Application for approval as an
accreditation body.
Electronic products, Health facilities,
Medical devices, Radiation protection,
Reporting and recordkeeping
requirements, X-rays.
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(b) * * *
(1) An applicant seeking initial FDA
approval as an accreditation body shall
inform the Division of Mammography
Quality Standards, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4445, Silver Spring,
MD 20993, Attn: Program Management
Branch, of its desire to be approved as
an accreditation body and of its
requested scope of authority.
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■ 5. Revise § 900.11(b)(2)(i) to read as
follows:
21 CFR Part 1020
§ 900.11
List of Subjects
21 CFR Part 890
Medical devices, Physical medicine
devices.
21 CFR Part 900
Electronic products, Medical devices,
Radiation protection, Reporting and
recordkeeping requirements, Television,
X-rays.
21 CFR Part 1040
Electronic funds transfers,
Incorporation by reference, Labeling,
Lasers, Medical devices, Radiation
protection, Reporting and recordkeeping
requirements.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR parts 890,
900, 1020, and 1040 are amended as
follows:
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Requirements for certification.
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(b) * * *
(2) * * *
(i) A new facility beginning operation
after October 1, 1994, is eligible to apply
for a provisional certificate. The
provisional certificate will enable the
facility to perform mammography and to
obtain the clinical images needed to
complete the accreditation process. To
apply for and receive a provisional
certificate, a facility must meet the
requirements of 42 U.S.C. 263b(c)(4) and
submit the necessary information to an
approved accreditation body or other
entity designated by FDA.
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PART 890—PHYSICAL MEDICINE
DEVICES
PART 1020—PERFORMANCE
STANDARDS FOR IONIZING
RADIATION EMITTING PRODUCTS
■
1. The authority citation for part 890
continues to read as follows:
■
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 360l, 371.
Authority: 21 U.S.C. 351, 352, 360e–360j,
360hh–360ss, 371, 381.
2. Revise § 890.5525(b)(2)(i)(A) to read
as follows:
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6. The authority citation for part 1020
continues to read as follows:
7. Revise § 1020.30(c) to read as
follows:
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§ 1020.30 Diagnostic x-ray systems and
their major components.
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(c) Manufacturers’ responsibility.
Manufacturers of products subject to
§§ 1020.30 through 1020.33 shall certify
that each of their products meets all
applicable requirements when installed
into a diagnostic x-ray system according
to instructions. This certification shall
be made under the format specified in
§ 1010.2 of this chapter. Manufacturers
may certify a combination of two or
more components if they obtain prior
authorization in writing from the
Director, Center for Devices and
Radiological Health. Manufacturers
shall not be held responsible for
noncompliance of their products if that
noncompliance is due solely to the
improper installation or assembly of
that product by another person;
however, manufacturers are responsible
for providing assembly instructions
adequate to assure compliance of their
components with the applicable
provisions of §§ 1020.30 through
1020.33.
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PART 1040—PERFORMANCE
STANDARDS FOR LIGHT-EMITTING
PRODUCTS
8. The authority citation for part 1040
continues to read as follows:
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Authority: 21 U.S.C. 351, 352, 360, 360e360j, 360hh-360ss, 371, 381.
9. In § 1040.10 revise paragraphs
(a)(3)(i), (f)(6)(ii), and (g)(10) to read as
follows:
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§ 1040.10
Laser products.
(a) * * *
(3) * * *
(i) Registers, and provides a listing by
type of such laser products
manufactured that includes the product
name, model number, and laser medium
or emitted wavelength(s), and the name
and address of the manufacturer. The
manufacturer must submit the
registration and listing to the Director,
Center for Devices and Radiological
Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66,
Silver Spring, MD 20993–0002.
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(f) * * *
(6) * * *
(ii) If the configuration, design, or
function of the laser product would
make unnecessary compliance with the
requirement in paragraph (f)(6)(i) of this
section, the Director, Center for Devices
and Radiological Health, may, upon
written application by the manufacturer,
approve alternate means to accomplish
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Federal Register / Vol. 83, No. 63 / Monday, April 2, 2018 / Rules and Regulations
the radiation protection provided by the
beam attenuator.
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(g) * * *
(10) Label specifications. Labels
required by this section and § 1040.11
shall be permanently affixed to, or
inscribed on, the laser product, legible,
and clearly visible during operation,
maintenance, or service, as appropriate.
If the size, configuration, design, or
function of the laser product would
preclude compliance with the
requirements for any required label or
would render the required wording of
such label inappropriate or ineffective,
the Director, Center for Devices and
Radiological Health, on the Director’s
own initiative or upon written
application by the manufacturer, may
approve alternate means of providing
such label(s) or alternate wording for
such label(s) as applicable.
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■ 10. In § 1040.20 revise paragraphs
(d)(3)(iii) and (iv) to read as follows:
§ 1040.20 Sunlamp products and
ultraviolet lamps intended for use in
sunlamp products.
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(d) * * *
(3) * * *
(iii) If the size, configuration, design,
or function of the sunlamp product or
ultraviolet lamp would preclude
compliance with the requirements for
any required label or would render the
required wording of such label
inappropriate or ineffective, or would
render the required label unnecessary,
the Director, Center for Devices and
Radiological Health, on the center’s own
initiative or upon written application by
the manufacturer, may approve alternate
means of providing such label(s),
alternate wording for such label(s), or
deletion, as applicable.
(iv) In lieu of permanently affixing or
inscribing tags or labels on the
ultraviolet lamp as required by
§§ 1010.2(b) and 1010.3(a), the
manufacturer of the ultraviolet lamp
may permanently affix or inscribe such
required tags or labels on the lamp
packaging uniquely associated with the
lamp, if the name of the manufacturer
and month and year of manufacture are
permanently affixed or inscribed on the
exterior surface of the ultraviolet lamp
so as to be legible and readily accessible
to view. The name of the manufacturer
and month and year of manufacture
affixed or inscribed on the exterior
surface of the lamp may be expressed in
code or symbols, if the manufacturer has
previously supplied the Director, Center
for Devices and Radiological Health,
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with the key to such code or symbols
and the location of the coded
information or symbols on the
ultraviolet lamp. The label or tag affixed
or inscribed on the lamp packaging may
provide either the month and year of
manufacture without abbreviation, or
information to allow the date to be
readily decoded.
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Dated: March 22, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–06308 Filed 3–30–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 117
[Docket No. USCG–2018–0110]
Drawbridge Operation Regulation;
Hackensack River, Jersey City, New
Jersey
Coast Guard, DHS.
Notice of deviation from
drawbridge regulation.
AGENCY:
ACTION:
The Coast Guard has issued a
temporary deviation from the operating
schedule that governs the PATH Bridge
across the Hackensack River, mile 3.0, at
Jersey City, New Jersey. This temporary
deviation is necessary to allow the
bridge to remain in the closed-tonavigation position to facilitate the
replacement of rails and timbers across
the length of the span of the bridge.
DATES: This deviation is effective from
12:01 a.m. on March 31, 2018, to 12:01
a.m. on September 26, 2018.
ADDRESSES: The docket for this
deviation, USCG–2018–0110 is available
at https://www.regulations.gov. Type the
docket number in the ‘‘SEARCH’’ box
and click ‘‘SEARCH.’’ Click on Open
Docket Folder on the line associated
with this deviation.
FOR FURTHER INFORMATION CONTACT: If
you have questions on this temporary
deviation, call or email Judy Leung-Yee,
Project Officer, First Coast Guard
District, telephone 212–514–4330, email
Judy.K.Leung-yee@uscg.mil.
SUPPLEMENTARY INFORMATION: The Port
Authority Trans-Hudson Corporation,
the owner of the bridge, requested a
temporary deviation from the normal
operating schedule to facilitate the
replacement of rails and timbers across
the length of the span of the bridge. The
PATH Bridge across the Hackensack
SUMMARY:
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13865
River, mile 3.0, has a vertical clearance
in the closed position of 40 feet at mean
high water and 45 feet at mean low
water. The existing bridge operating
regulations are listed at 33 CFR
117.723(b).
Under this temporary deviation, the
PATH Bridge shall remain in the closed
position between 12:01 a.m. Saturday
and 12:01 a.m. Monday as follows:
March 31–April 2, 2018; April 7–9, 14–
16, 21–23, and 28–30, 2018; May 5–7,
12–14, and 19–21, 2018; June 2–4, 9–11,
16–18, 23–25, and 30-July 2, 2018; July
7–9, 14–16, 21–23, and 28–30, 2018;
August 4–6, 11–13, 18–20, and 25–27,
2018; September 8–10, 15–17, 22–24,
2018.
The waterway is transited by
commercial and recreational traffic. The
Coast Guard notified known companies
of the commercial vessels that transit
the area, including the Sandy Hook
Pilots and the local Tug/Tow
Committee; there were no objections to
this temporary deviation. Vessels able to
pass under the bridge in the closed
position may do so at any time. The
bridge will not be able to open for
emergencies and there is no immediate
alternate route for vessels to pass.
The Coast Guard will inform the users
of the waterways through our Local and
Broadcast Notices to Mariners of the
change in operating schedule for the
bridge so that vessel operations can
arrange their transits to minimize any
impact caused by the temporary
deviation.
In accordance with 33 CFR 117.35(e),
the drawbridge must return to its regular
operating schedule immediately at the
end of the effective period of this
temporary deviation. This deviation
from the operating regulations is
authorized under 33 CFR 117.35.
Dated: March 27, 2018.
Christopher J. Bisignano,
Supervisory Bridge Management Specialist,
First Coast Guard District.
[FR Doc. 2018–06540 Filed 3–30–18; 8:45 am]
BILLING CODE 9110–04–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 117
[Docket No. USCG–2018–0253]
Drawbridge Operation Regulation;
Lake Washington Ship Canal, Seattle,
WA
AGENCY:
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Coast Guard, DHS.
02APR1
]]>Agencies
[Federal Register Volume 83, Number 63 (Monday, April 2, 2018)]
[Rules and Regulations]
[Pages 13863-13865]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-06308]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 890, 900, 1020, and 1040
[Docket No. FDA-2018-N-0011]
Medical Devices; Technical Amendment
AGENCY: Food and Drug Administration; HHS.
ACTION: Final rule; technical amendment.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is amending
certain medical device regulations. This action is editorial in nature
to correct typographical errors and to ensure accuracy and clarity in
the Agency's regulations.
DATES: This rule is effective April 2, 2018.
FOR FURTHER INFORMATION CONTACT: Karen Fikes, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5244, Silver Spring, MD 20993-0002, 301-796-9603.
SUPPLEMENTARY INFORMATION: FDA is amending our regulations in 21 CFR
parts 890, 900, 1020, and 1040 to correct typographical errors and to
update addresses, office titles, and wording to ensure accuracy and
clarity in the Agency's medical device regulations.
FDA is making nonsubstantive changes to the following regulations:
1. FDA is revising Sec. 890.5525(b)(2)(i)(A) by replacing
``Testing using a drug approved for iontophoretic delivery, or a
solution, if identified in the labeling, to demonstrate safe use of the
device as intended'' with ``Testing using a drug approved for
iontophoretic delivery, or a solution if identified in the labeling, to
demonstrate safe use of the device as intended''.
2. FDA is revising Sec. 900.3(b)(1) by replacing ``Division of
Mammography Quality and Radiation Programs (DMQRP), Center for Devices
and Radiology Health (HFZ-240), Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20850, marked Attn: Mammography Standards
Branch'' with ``Division of Mammography Quality Standards, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 4445, Silver Spring, MD 20993, Attn:
Program Management Branch''.
3. FDA is revising Sec. 900.11(b)(2)(i) by replacing ``42 U.S.C.
263b(c)(2)'' with ``42 U.S.C. 263b(c)(4)''.
4. FDA is revising Sec. 1020.30(c) by replacing ``Director of the
Office of Communication, Education, and Radiation Programs of the
Center for Devices and Radiological Health'' with ``Director, Center
for Devices and Radiological Health''.
5. FDA is revising Sec. 1040.10(a)(3)(i) by replacing ``Food and
Drug Administration, Center for Devices and Radiological Health,
Director, Office of Compliance, 10903 New Hampshire Ave., Bldg. 66, Rm.
3521, Silver Spring, MD 20993-0002'' with ``Director, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Silver Spring, MD 20993-0002''.
6. FDA is revising Sec. 1040.10(f)(6)(ii) by replacing ``Director,
Office of
[[Page 13864]]
Compliance (HFZ-300), Center for Devices and Radiological Health'' with
``Director, Center for Devices and Radiological Health''.
7. FDA is revising Sec. 1040.10(g)(10) by replacing ``Director,
Office of Compliance (HFZ-300), Center for Devices and Radiological
Health'' with ``Director, Center for Devices and Radiological Health''.
8. FDA is revising Sec. 1040.20(d)(3)(iii) by replacing
``Director, Office of Communication, Education, and Radiation Programs
10903 New Hampshire Ave., Bldg. 66, Rm. 4312, Silver Spring, MD 20993-
0002, Center for Devices and Radiological Health'' with ``Director,
Center for Devices and Radiological Health''.
9. FDA is revising Sec. 1040.20(d)(3)(iv) by replacing
``manfacturer'' with ``manufacturer,'' and replacing ``Director, Office
of Compliance (HFZ-300), Center for Devices and Radiological Health''
with ``Director, Center for Devices and Radiological Health''.
List of Subjects
21 CFR Part 890
Medical devices, Physical medicine devices.
21 CFR Part 900
Electronic products, Health facilities, Medical devices, Radiation
protection, Reporting and recordkeeping requirements, X-rays.
21 CFR Part 1020
Electronic products, Medical devices, Radiation protection,
Reporting and recordkeeping requirements, Television, X-rays.
21 CFR Part 1040
Electronic funds transfers, Incorporation by reference, Labeling,
Lasers, Medical devices, Radiation protection, Reporting and
recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
890, 900, 1020, and 1040 are amended as follows:
PART 890--PHYSICAL MEDICINE DEVICES
0
1. The authority citation for part 890 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
2. Revise Sec. 890.5525(b)(2)(i)(A) to read as follows:
Sec. 890.5525 Iontophoresis device.
* * * * *
(b) * * *
(2) * * *
(i) * * *
(A) Testing using a drug approved for iontophoretic delivery, or a
solution if identified in the labeling, to demonstrate safe use of the
device as intended;
* * * * *
PART 900--MAMMOGRAPHY
0
3. The authority citation for part 900 continues to read as follows:
Authority: 21 U.S.C. 360i, 360nn, 374(e), 42 U.S.C. 263b.
0
4. Revise Sec. 900.3(b)(1) to read as follows:
Sec. 900.3 Application for approval as an accreditation body.
* * * * *
(b) * * *
(1) An applicant seeking initial FDA approval as an accreditation
body shall inform the Division of Mammography Quality Standards, Center
for Devices and Radiological Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66, Rm. 4445, Silver Spring, MD 20993,
Attn: Program Management Branch, of its desire to be approved as an
accreditation body and of its requested scope of authority.
* * * * *
0
5. Revise Sec. 900.11(b)(2)(i) to read as follows:
Sec. 900.11 Requirements for certification.
* * * * *
(b) * * *
(2) * * *
(i) A new facility beginning operation after October 1, 1994, is
eligible to apply for a provisional certificate. The provisional
certificate will enable the facility to perform mammography and to
obtain the clinical images needed to complete the accreditation
process. To apply for and receive a provisional certificate, a facility
must meet the requirements of 42 U.S.C. 263b(c)(4) and submit the
necessary information to an approved accreditation body or other entity
designated by FDA.
* * * * *
PART 1020--PERFORMANCE STANDARDS FOR IONIZING RADIATION EMITTING
PRODUCTS
0
6. The authority citation for part 1020 continues to read as follows:
Authority: 21 U.S.C. 351, 352, 360e-360j, 360hh-360ss, 371,
381.
0
7. Revise Sec. 1020.30(c) to read as follows:
Sec. 1020.30 Diagnostic x-ray systems and their major components.
* * * * *
(c) Manufacturers' responsibility. Manufacturers of products
subject to Sec. Sec. 1020.30 through 1020.33 shall certify that each
of their products meets all applicable requirements when installed into
a diagnostic x-ray system according to instructions. This certification
shall be made under the format specified in Sec. 1010.2 of this
chapter. Manufacturers may certify a combination of two or more
components if they obtain prior authorization in writing from the
Director, Center for Devices and Radiological Health. Manufacturers
shall not be held responsible for noncompliance of their products if
that noncompliance is due solely to the improper installation or
assembly of that product by another person; however, manufacturers are
responsible for providing assembly instructions adequate to assure
compliance of their components with the applicable provisions of
Sec. Sec. 1020.30 through 1020.33.
* * * * *
PART 1040--PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS
0
8. The authority citation for part 1040 continues to read as follows:
Authority: 21 U.S.C. 351, 352, 360, 360e-360j, 360hh-360ss,
371, 381.
0
9. In Sec. 1040.10 revise paragraphs (a)(3)(i), (f)(6)(ii), and
(g)(10) to read as follows:
Sec. 1040.10 Laser products.
(a) * * *
(3) * * *
(i) Registers, and provides a listing by type of such laser
products manufactured that includes the product name, model number, and
laser medium or emitted wavelength(s), and the name and address of the
manufacturer. The manufacturer must submit the registration and listing
to the Director, Center for Devices and Radiological Health, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Silver Spring,
MD 20993-0002.
* * * * *
(f) * * *
(6) * * *
(ii) If the configuration, design, or function of the laser product
would make unnecessary compliance with the requirement in paragraph
(f)(6)(i) of this section, the Director, Center for Devices and
Radiological Health, may, upon written application by the manufacturer,
approve alternate means to accomplish
[[Page 13865]]
the radiation protection provided by the beam attenuator.
* * * * *
(g) * * *
(10) Label specifications. Labels required by this section and
Sec. 1040.11 shall be permanently affixed to, or inscribed on, the
laser product, legible, and clearly visible during operation,
maintenance, or service, as appropriate. If the size, configuration,
design, or function of the laser product would preclude compliance with
the requirements for any required label or would render the required
wording of such label inappropriate or ineffective, the Director,
Center for Devices and Radiological Health, on the Director's own
initiative or upon written application by the manufacturer, may approve
alternate means of providing such label(s) or alternate wording for
such label(s) as applicable.
* * * * *
0
10. In Sec. 1040.20 revise paragraphs (d)(3)(iii) and (iv) to read as
follows:
Sec. 1040.20 Sunlamp products and ultraviolet lamps intended for use
in sunlamp products.
* * * * *
(d) * * *
(3) * * *
(iii) If the size, configuration, design, or function of the
sunlamp product or ultraviolet lamp would preclude compliance with the
requirements for any required label or would render the required
wording of such label inappropriate or ineffective, or would render the
required label unnecessary, the Director, Center for Devices and
Radiological Health, on the center's own initiative or upon written
application by the manufacturer, may approve alternate means of
providing such label(s), alternate wording for such label(s), or
deletion, as applicable.
(iv) In lieu of permanently affixing or inscribing tags or labels
on the ultraviolet lamp as required by Sec. Sec. 1010.2(b) and
1010.3(a), the manufacturer of the ultraviolet lamp may permanently
affix or inscribe such required tags or labels on the lamp packaging
uniquely associated with the lamp, if the name of the manufacturer and
month and year of manufacture are permanently affixed or inscribed on
the exterior surface of the ultraviolet lamp so as to be legible and
readily accessible to view. The name of the manufacturer and month and
year of manufacture affixed or inscribed on the exterior surface of the
lamp may be expressed in code or symbols, if the manufacturer has
previously supplied the Director, Center for Devices and Radiological
Health, with the key to such code or symbols and the location of the
coded information or symbols on the ultraviolet lamp. The label or tag
affixed or inscribed on the lamp packaging may provide either the month
and year of manufacture without abbreviation, or information to allow
the date to be readily decoded.
* * * * *
Dated: March 22, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-06308 Filed 3-30-18; 8:45 am]
BILLING CODE 4164-01-P
