2010-7288. Medical Devices; Technical Amendment

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule; technical amendment.

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 § 1002.30(b) by deleting “paragraph (c) of § 1002.61” and replacing it with “table 1 of § 1002.1.” FDA updated § 1002.30(a) to reflect this change, but inadvertently retained the reference to “paragraph (c) of § 1002.61” in § 1002.30(b). With this technical amendment, the entirety of the regulation at § 1002.30 accurately references “table 1 of § 1002.1,” which is the former paragraph (c) of § 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 §§ 1002.41(a)(1) and 1002.42 by replacing section “359” of the act with section “535.” FDA is revising § 1005.25(c) by replacing section “360(d)” of the act with section “536(d).” FDA is revising § 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

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

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.

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

§ 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 § 1002.1 shall establish and maintain the following records with respect to such products:

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

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

4. Section 1002.42 is revised to read as follows:

§ 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

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

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

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

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

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

§ 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

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.

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

§ 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

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

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

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

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.