Document ID: FDA-2010-N-0010-0002
Agency: fda
Document Type: Rule
Title: Technical Amendments: Medical Devices
Posted Date: 2010-04-01T04:00Z

[Federal Register: April 1, 2010 (Volume 75, Number 62)]
[Rules and Regulations]               
[Page 16351-16353]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01ap10-14]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1002, 1003, 1004, 1005, 1010, 1020, 1030, 1040, and 
1050

[Docket No. FDA-2010-N-0010]

 
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) is amending certain 
medical device regulations to correct statutory and regulatory 
references to ensure accuracy, consistency, and clarity in the agency's 
regulations.

DATES:  This rule is effective April 1, 2010.

FOR FURTHER INFORMATION CONTACT: Bernice E. Noland, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, rm. 4430, Silver Spring, MD 20993-0002, 301-
796-5742.

SUPPLEMENTARY INFORMATION: FDA is amending its regulations at part 1002 
(21 CFR part 1002) to correct a regulatory reference. FDA is revising 
Sec.  1002.30(b) by deleting ``paragraph (c) of Sec.  1002.61'' and 
replacing it with ``table 1 of Sec.  1002.1.'' FDA updated

[[Page 16352]]

Sec.  1002.30(a) to reflect this change, but inadvertently retained the 
reference to ``paragraph (c) of Sec.  1002.61'' in Sec.  1002.30(b). 
With this technical amendment, the entirety of the regulation at Sec.  
1002.30 accurately references ``table 1 of Sec.  1002.1,'' which is the 
former paragraph (c) of Sec.  1002.61.
    In addition, FDA is amending its regulations at part 1002 and parts 
1005 and 1010 (21 CFR parts 1005 and 1010) to correct statutory 
references. These parts intermittently cite sections of the Radiation 
Control for Health and Safety Act of 1968 (Radiation Control Act) 
(Public Law 90-602). However, ``Act'' is defined in 21 CFR 1000.3(b), 
and applicable throughout 21 CFR parts 1000 to 1050, subchapter J, to 
mean the Federal Food, Drug, and Cosmetic Act (FFDCA) (21 U.S.C. 360hh-
360ss). The Safe Medical Devices Act of 1990 (SMDA) (Public Law 101-
629), transferred the Radiation Control Act to the FFDCA. With these 
technical amendments, FDA is replacing citations to the Radiation 
Control Act with citations to the corresponding sections of the FFDCA. 
FDA is revising Sec. Sec.  1002.41(a)(1) and 1002.42 by replacing 
section ``359'' of the act with section ``535.'' FDA is revising Sec.  
1005.25(c) by replacing section ``360(d)'' of the act with section 
``536(d).'' FDA is revising Sec.  1010.4(c)(3) by replacing section 
``360A(e)'' of the act with section ``537(e).''
    Finally, FDA is amending its authority citations in parts 1003, 
1004, 1005, 1010, 1020, 1030, 1040, and 1050 to correct statutory 
citations. These parts cite to the Public Health Service Act, which 
codified the Radiation Control Act at 42 U.S.C. 263b-263n, until the 
SMDA transferred the Radiation Control Act to the FFDCA. Section 
19(a)(3) of the SMDA also repealed section 354 of the Radiation Control 
Act, codified at 42 U.S.C. 263b, which contained Congress's declaration 
of purpose in enacting the program of electronic product radiation 
controls. The SMDA redesignated and transferred the remaining sections 
to the FFDCA at 21 U.S.C. 360hh-360ss. The authority citations in parts 
1003, 1004, 1005, 1010, 1020, 1030, 1040, and 1050 to 42 U.S.C. 263b-
263n were not correspondingly updated to reflect the transfer of the 
Radiation Control Act from the Public Health Service Act to the FFDCA. 
With these technical amendments, FDA is replacing citations to the 
Public Health Service Act with citations to the corresponding sections 
of the FFDCA. Thus, FDA is revising parts 1003, 1004, 1010, 1030, 1040, 
and 1050 by replacing the authority citation of ``42 U.S.C. 263b-263n'' 
with ``21 U.S.C. 360hh-360ss.'' FDA is similarly revising part 1005 by 
replacing the authority citation of ``42 U.S.C. 263d, 263h'' with ``21 
U.S.C. 360ii, 360mm.'' FDA is also revising part 1020 by deleting the 
authority citation to 21 U.S.C. 360gg. Although section 354 of the 
Radiation Control Act would have been designated as 21 U.S.C. 360gg had 
the provision been transferred to the FFDCA, the SMDA repealed that 
section. As a result, the citation to 21 U.S.C. 360gg in part 1020 is 
an inadvertent error that this technical amendment will correct by 
deleting that part of the authority citation.
    Publication of this document constitutes final action on the change 
under the Administrative Procedure Act (5 U.S.C. 553). These technical 
amendments correct regulatory and statutory references in the Code of 
Federal Regulations. FDA therefore, for good cause, has determined that 
notice and public comment are unnecessary, under 5 U.S.C. 553(b)(3)(B). 
Further, this rule places no burden on affected parties for which such 
parties would need a reasonable time to prepare for the effective date 
of the rule. Accordingly, FDA, for good cause, had determined this 
technical amendment to be exempt under 5 U.S.C. 553(d)(3) from the 30-
day effective date from publication.
    FDA has determined under 21 CFR 25.30(i) that this final rule is of 
a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required. In 
addition, FDA has determined that this final rule contains no 
collections of information. Therefore, clearance by the Office 
Management and Budget under the Paperwork Reduction Act of 1995 is not 
required.
    For the effective date of this final rule, see the DATES section of 
this document.

List of Subjects

21 CFR Part 1002

    Electronic products, Radiation protection, Reporting and 
recordkeeping requirements.

21 CFR Part 1003

    Administrative practice and procedure, Electronic products, 
Radiation protection.

21 CFR Part 1004

    Electronic products, Radiation protection.

21 CFR Part 1005

    Administrative practice and procedure, Electronic products, 
Imports, Radiation protection, Surety bonds.

21 CFR Part 1010

    Administrative practice and procedure, Electronic products, 
Exports, Radiation protection.

21 CFR Part 1020

    Electronic products, Medical devices, Radiation protection, 
Reporting and recordkeeping requirements, Television, X-rays.

21 CFR Part 1030

    Electronic products, Microwave ovens, Radiation protection.

21 CFR Part 1040

    Electronic products, Labeling, Lasers, Medical devices, Radiation 
protection, Reporting and recordkeeping requirements.

21 CFR Part 1050

    Electronic products, Medical devices, Radiation protection.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act, and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR 
Chapter I is amended as follows:

PART 1002--RECORDS AND REPORTS

0
1. The authority citation for 21 CFR part 1002 continues to read as 
follows:

    Authority: 21 U.S.C. 352, 360, 360i, 360j, 360hh-360ss, 371, 
374.

0
2. In Sec.  1002.30, paragraph (b) introductory text is revised to read 
as follows:

Sec.  1002.30  Records to be maintained by manufacturers.

* * * * *
    (b) In addition to the records required by paragraph (a) of this 
section, manufacturers of products listed in table 1 of Sec.  1002.1 
shall establish and maintain the following records with respect to such 
products:
* * * * *

0
3. In 1002.41, paragraph (a)(1) is revised to read as follows:

Sec.  1002.41  Disposition of records obtained by dealers and 
distributors.

    (a) * * *
    (1) The dealer or distributor elects to hold and preserve such 
information and to immediately furnish it to the manufacturer when 
advised by the manufacturer or the Director, Center for Devices and 
Radiological Health, that

[[Page 16353]]

such information is required for purposes of section 535 of the Act; 
and
* * * * *

0
4. Section 1002.42 is revised to read as follows:

Sec.  1002.42  Confidentiality of records furnished by dealers and 
distributors.

    All information furnished to manufacturers by dealers and 
distributors pursuant to this part shall be treated by such 
manufacturers as confidential information which may be used only as 
necessary to notify persons pursuant to section 535 of the Act.

PART 1003--NOTIFICATION OF DEFECTS OR FAILURE TO COMPLY

0
5. The authority citation for 21 CFR part 1003 is revised to read as 
follows:

    Authority: 21 U.S.C. 360hh-360ss.

PART 1004--REPURCHASE, REPAIRS, OR REPLACEMENT OF ELECTRONIC 
PRODUCTS

0
6. The authority citation for 21 CFR part 1004 is revised to read as 
follows:

    Authority: 21 U.S.C. 360hh-360ss.

PART 1005--IMPORTATION OF ELECTRONIC PRODUCTS

0
7. The authority citation for 21 CFR part 1005 is revised to read as 
follows:

    Authority: 21 U.S.C. 360ii, 360mm.

0
8. In 1005.25, paragraph (c) is revised to read as follows:

Sec.  1005.25  Service of process on manufacturers.

* * * * *
    (c) Service of any process, notice, order, requirement, or decision 
specified in section 536(d) of Subchapter C--Electronic Product 
Radiation Control of the Federal Food, Drug, and Cosmetic Act (formerly 
the Radiation Control for Health and Safety Act of 1968) (21 U.S.C. 
360mm(d)) may be made by registered or certified mail addressed to the 
agent with return receipt requested, or in any other manner authorized 
by law. In the absence of such a designation or if for any reason 
service on the designated agent cannot be effected, service may be made 
as provided in section 536(d) by posting such process, notice, order, 
requirement, or decision in the Office of the Director, Center for 
Devices and Radiological Health and publishing a notice that such 
service was made in the Federal Register.

PART 1010--PERFORMANCE STANDARDS FOR ELECTRONIC PRODUCTS: GENERAL

0
9. The authority citation for 21 CFR part 1010 is revised to read as 
follows:

    Authority: 21 U.S.C. 351, 352, 360, 360e-360j, 360hh-360ss, 371, 
381.

0
10. In 1010.4, paragraph (c)(3) is revised to read as follows:

Sec.  1010.4  Variances.

* * * * *
    (c) * * *
    (3) All applications for variances and for amendments and 
extensions thereof and all correspondence (including written notices of 
approval) on these applications will be available for public disclosure 
in the office of the Division of Dockets Management, except for 
information regarded as confidential under section 537(e) of the act.
* * * * *

PART 1020--PERFORMANCE STANDARDS FOR IONIZING RADIATION EMITTING 
PRODUCTS

0
11. The authority citation for 21 CFR part 1020 is revised to read as 
follows:

    Authority: 21 U.S.C. 351, 352, 360e-360j, 360hh-360ss, 371, 381.

PART 1030--PERFORMANCE STANDARDS FOR MICROWAVE AND RADIO FREQUENCY 
EMITTING PRODUCTS

0
12. The authority citation for 21 CFR part 1030 is revised to read as 
follows:

    Authority: 21 U.S.C. 351, 352, 360, 360e-360j, 360hh-360ss, 371, 
381.

PART 1040--PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS

0
13. The authority citation for 21 CFR part 1040 is revised to read as 
follows:

    Authority: 21 U.S.C. 351, 352, 360, 360e-360j, 360hh-360ss, 371, 
381.

PART 1050--PERFORMANCE STANDARDS FOR SONIC, INFRASONIC, AND 
ULTRASONIC RADIATION-EMITTING PRODUCTS

0
14. The authority citation for 21 CFR part 1050 is revised to read as 
follows:

    Authority: 21 U.S.C. 351, 352, 360, 360e-360j, 360hh-360ss, 371, 
381.

    Dated: March 29, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-7288 Filed 3-31-10; 8:45 am]
BILLING CODE 4160-01-S