Document ID: FDA-2018-N-0011-0003
Agency: fda
Document Type: Rule
Title: Medical Devices: Technical Amendment
Posted Date: 2018-04-02T04:00Z

[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.

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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