2010-8863. Center for Devices and Radiological Health; New Address Information

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule; technical amendments.

SUMMARY:

The Food and Drug Administration (FDA) is amending procedural regulations that pertain to obtaining, submitting, executing, and filing certain documents to reflect new address information for the Center for Devices and Radiological Health (CDRH). All filings and other documents that are subject to these regulations must be directed to the new addresses. This action is being taken to provide accuracy and clarity to the agency's regulations.

DATES:

This regulation is effective April 22, 2010.

FOR FURTHER INFORMATION CONTACT:

Domini Bean, Food and Drug Administration, Center for Devices and Radiological Health, 10903 New Hampshire Ave., Bldg. 66, rm. 4422, Silver Spring, MD 20993-0002, 301-796-5733.

SUPPLEMENTARY INFORMATION:

FDA is amending its regulations in 21 CFR parts 1, 801, 803, 807, 812, 814, 820, 822, 860, 900, 1002, and 1040 to reflect new address information for certain components of the agency's CDRH. The changes are the result of the relocation of these offices to FDA's White Oak campus.

Publication of this document constitutes final action under the Administrative Procedures Act (5 U.S.C. 553). FDA has determined that notice and public comment are unnecessary because this amendment to the regulations provides only technical changes to update mailing addresses and other information, and is nonsubstantive.

List of Subjects

21 CFR Part 1

• Cosmetics
• Drugs
• Exports
• Food labeling
• Imports
• Labeling
• Reporting and recordkeeping requirements

21 CFR Part 801

• Incorporation by reference
• Labeling
• Medical devices
• Reporting and recordkeeping requirements

21 CFR Part 803

• Imports
• Medical devices
• Reporting and recordkeeping requirements

21 CFR Part 807

• Confidential business information
• Imports
• Medical devices
• Reporting and recordkeeping requirements

21 CFR Part 812

• Health records
• Medical devices
• Medical research
• Reporting and recordkeeping requirements

21 CFR Part 814

• Administrative practice and procedure
• Confidential business information
• Medical devices
• Medical research
• Reporting and recordkeeping requirements

21 CFR Parts 820 and 822

• Medical devices
• Reporting and recordkeeping requirements

21 CFR Part 860

• Administrative practice and procedure
• Medical devices

21 CFR Part 900

• Electronic products
• Health facilities
• Medical devices
• Radiation protection
• Reporting and recordkeeping requirements
• X-rays

21 CFR Part 1002

• Electronic products
• Radiation protection
• Reporting and recordkeeping requirements

21 CFR Part 1040

• Electronic products
• 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 Chapter I is amended as follows:

PART 1—GENERAL ENFORCEMENT REGULATIONS

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

Authority: 15 U.S.C. 1453, 1454, 1455; 19 U.S.C. 1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 343, 350c, 350d, 352, 355, 360b, 362, 371, 374, 381, 382, 393; 42 U.S.C. 216, 241, 243, 262, 264.

2. Section 1.101 is amended by revising paragraph (d)(2)(iii) to read as follows:

§ 1.101

Notification and recordkeeping.

(d) * * *

(2) * * *

(iii) For devices—Food and Drug Administration, Center for Devices and Radiological Health, Division of Program Operations, 10903 New Hampshire Ave., Bldg. 66, rm. 5429, Silver Spring, MD 20993-0002.

PART 801—LABELING

3. The authority citation for 21 CFR part 801 continues to read as follows:

Authority: 21 U.S.C. 321, 331, 351, 352, 360i, 360j, 371, 374.

4. Section 801.430 is amended by revising the text of footnote number 1 in paragraph (f)(2) to read as follows:

§ 801.430

User labeling for menstrual tampons.

(f) * * *

(2) * * *

¹ The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain a copy from the American Society for Testing and Materials International, 100 Barr Harbor Dr., P.O. Box C700, West Conshohocken, PA 19428-2959, 610-832-9578, www.astm.org. You may inspect a copy at the FDA Main Library, 10903 New Hampshire Ave., Bldg. 2, 3d floor, Silver Spring, MD 20993-0002, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-2139, or go to: http://www.archives.gov/​federal_​register/​code_​of_​federal_​regulations/​ibr_​locations.html.

PART 803—MEDICAL DEVICE REPORTING

5. The authority citation for 21 CFR part 803 continues to read as follows:

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

6. Section 803.11 is amended by revising paragraph (c) to read as follows:

§ 803.11

What form should I use to submit reports of individual adverse events and where do I obtain these forms?

(c) Food and Drug Administration, Center for Devices and Radiological Health, Division of Small Manufacturers, International and Consumer Assistance, 10903 New Hampshire Ave., Bldg. 66, rm. 4521, Silver Spring, MD 20993-0002.

7. Section 803.21 is amended by revising paragraph (a) to read as follows:

§ 803.21

Where can I find the reporting codes for adverse events that I use with medical device reports?

(a) The MEDWATCH Medical Device Reporting Code Instruction Manual contains adverse event codes for use with FDA Form 3500A. You may obtain the coding manual from CDRH's Web site at http://www.fda.gov/​Safety/​MedWatch/​HowToReport/​DownloadForms/​ucm149238.htm.

PART 807—ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES

8. The authority citation for 21 CFR part 807 continues to read as follows:

Authority: 21 U.S.C. 321, 331, 351, 352, 360, 360c, 360e, 360i, 360j, 371, 374, 381, 393; 42 U.S.C. 264, 271.

9. Section 807.22 is amended by revising paragraph (a) to read as follows:

§ 807.22

How and where to register establishments and list devices.

(a) The first registration of a device establishment shall be on Form FDA-2891 (Initial Registration of Device Establishment). Forms are available upon request from the Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, 10903 New Hampshire Ave., Bldg. 66, rm. 3521, Silver Spring, MD 20993-0002, or from Food and Drug Administration district offices. Subsequent annual registration shall be accomplished on Form FDA-2891a (Annual Registration of Device Establishment), which will be furnished by FDA to establishments whose registration for that year was validated under § 807.35(a). The forms will be mailed to the owner or operators of all establishments by the official correspondent in accordance with the schedule as described in § 807.21(a). The completed form shall be mailed to the address designated in this paragraph 30 days after receipt from FDA.

10. Section 807.37 is amended by revising paragraphs (a) and (b)(2) to read as follows:

§ 807.37

Inspection of establishment registration and device listings.

(a) A copy of the forms FDA-2891 and FDA-2891a filed by the registrant will be available for inspection in accordance with section 510(f) of the act, at the Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, 10903 New Hampshire Ave., Bldg. 66, rm. 3521, Silver Spring, MD 20993-0002. In addition, there will be available for inspection at each of the Food and Drug Administration district offices the same information for firms within the geographical area of such district office. Upon request, verification of registration number or location of a registered establishment will be provided.

(b) * * *

(2) Requests for device listing information identified in paragraph (b)(1) of this section should be directed to the Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, 10903 New Hampshire Ave., Bldg. 66, rm. 3521, Silver Spring, MD 20993-0002.

11. Section 807.90 is amended by revising paragraph (a)(1) to read as follows:

§ 807.90

Format of a premarket notification submission.

(a)(1) For devices regulated by the Center for Devices and Radiological Health, be addressed to the Food and Drug Administration, Center for Devices and Radiological Health, Document Mail Center, 10903 New Hampshire Ave., Bldg. 66, rm. G609, Silver Spring, MD 20993-0002.

PART 812—INVESTIGATIONAL DEVICE EXEMPTIONS

12. The authority citation for 21 CFR part 812 continues to read as follows:

Authority: 21 U.S.C. 331, 351, 352, 353, 355, 360, 360c-360f, 360h-360j, 371, 372, 374, 379e, 381, 382, 383; 42 U.S.C. 216, 241, 262, 263b-263n.

13. Section 812.19 is amended by revising paragraph (a)(1) to read as follows:

§ 812.19

Address for IDE correspondence.

(a) * * *

(1) For devices regulated by the Center for Devices and Radiological Health, send it to Food and Drug Administration, Center for Devices and Radiological Health, Document Mail Center, 10903 New Hampshire Ave., Bldg. 66, rm. G609, Silver Spring, MD 20993-0002.

PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES

14. The authority citation for 21 CFR part 814 continues to read as follows:

Authority: 21 U.S.C. 351, 352, 353, 360, 360c-360j, 371, 372, 373, 374, 375, 379, 379e, 381.

15. Section 814.20 is amended by revising paragraph (h)(1) to read as follows:

§ 814.20

Application.

(h) * * *

(1) For devices regulated by the Center for Devices and Radiological Health, Food and Drug Administration, Center for Devices and Radiological Health, Document Mail Center, 10903 New Hampshire Ave., Bldg. 66, rm. G609, Silver Spring, MD 20993-0002.

16. Section 814.104 is amended by revising paragraph (d)(1) to read as follows:

§ 814.104

Original applications.

(d) * * *

(1) For devices regulated by the Center for Devices and Radiological Health, send to Document Mail Center, 10903 New Hampshire Ave., Bldg. 66, rm. G609, Silver Spring, MD 20993-0002.

PART 820—QUALITY SYSTEM REGULATION

17. The authority citation for 21 CFR part 820 continues to read as follows:

Authority: 21 U.S.C. 351, 352, 360, 360c, 360d, 360e, 360h, 360i, 360j, 360l, 371, 374, 381, 383; 42 U.S.C. 216, 262, 263a, 264.

18. Section 820.1 is amended by revising paragraph (e)(1) to read as follows:

§ 820.1

Scope.

(e) * * * (1) Any person who wishes to petition for an exemption or variance from any device quality system requirement is subject to the requirements of section 520(f)(2) of the act. Petitions for an exemption or variance shall be submitted according to the procedures set forth in § 10.30 of this chapter, the FDA's administrative procedures. Guidance is available from the Food and Drug Administration, Center for Devices and Radiological Health, Division of Small Manufacturers, International and Consumer Assistance, 10903 New Hampshire Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993-0002, 1-800-638-2041 or 301-796-7100, FAX: [phone].

PART 822—POSTMARKET SURVEILLANCE

19. The authority citation for 21 CFR part 822 continues to read as follows:

Authority: 21 U.S.C. 331, 352, 360i, 360l, 371, 374.

20. Section 822.8 is revised to read as follows:

§ 822.8

When, where, and how must I submit my postmarket surveillance plan?

You must submit your plan to conduct postmarket surveillance within 30 days of the date you receive the postmarket surveillance order. For devices regulated by the Center for Biologics Evaluation and Research, send three copies of your submission to the Document Control Center (HFM-99), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448. For devices regulated by the Center for Drug Evaluation and Research, send three copies of your submission to the Central Document Room, Center for Drug Evaluation and Research, Food and Drug Administration, 5901-B, Ammendale Rd., Beltsville, MD 20705-1266. For devices regulated by the Center for Devices and Radiological Health, send three copies of your submission to the Document Mail Center, 10903 New Hampshire Ave., Bldg. 66, rm. G609, Silver Spring, MD 20993-0002. When we receive your original submission, we will send you an acknowledgment letter identifying the unique document number assigned to your submission. You must use this number in any correspondence related to this submission.

21. Section 822.12 is revised to read as follows:

§ 822.12

Do you have any information that will help me prepare my submission or design my postmarket surveillance plan?

Guidance documents that discuss our current thinking on preparing a postmarket surveillance submission and designing a postmarket surveillance plan are available on the Center for Devices and Radiological Health's Web site and from the Food and Drug Administration, Center for Devices and Radiological Health, Office of Surveillance and Biometrics, 10903 New Hampshire Ave., Bldg. 66, rm. 3219, Silver Spring, MD 20993-0002. Guidance documents represent our current interpretation of, or policy on, a regulatory issue. They do not establish legally enforceable rights or responsibilities and do not legally bind you or FDA. You may choose to use an approach other than the one set forth in a guidance document, as long as your alternative approach complies with the relevant statutes (laws) and regulations. If you wish, we will meet with you to discuss whether an alternative approach you are considering will satisfy the requirements of the act and regulations.

PART 860—MEDICAL DEVICE CLASSIFICATION PROCEDURES

22. The authority citation for 21 CFR part 860 continues to read as follows:

Authority: 21 U.S.C. 360c, 360d, 360e, 360i, 360j, 371, 374.

23. Section 860.123 is amended by revising paragraph (b)(1) to read as follows:

§ 860.123

Reclassification petition: Content and form.

(b) * * *

(1) For devices regulated by the Center for Devices and Radiological Health, addressed to the Food and Drug Administration, Center for Devices and Radiological Health, Regulations Staff, 10903 New Hampshire Ave., Bldg. 66, rm. 4425, Silver Spring, MD 20993-0002; for devices regulated by the Center for Biologics Evaluation and Research, addressed to the Document Control Center (HFM-99), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448; for devices regulated by the Center for Drug Evaluation and Research, addressed to the Central Document Control Room, Center for Drug Evaluation and Research, Food and Drug Administration, 5901-B Ammendale Rd., Beltsville, MD 20705-1266, as applicable.

PART 900—MAMMOGRAPHY

24. The authority citation for 21 CFR part 900 continues to read as follows:

Authority: 21 U.S.C. 360i, 360nn, 374(e); 42 U.S.C. 263b.

25. Section 900.15 is amended by revising paragraph (d)(3)(i) to read as follows:

§ 900.15

Appeals of adverse accreditation or reaccreditation decisions that preclude certification or recertification.

(d) * * *

(3) * * *

(i) A facility must request reconsideration by DMQRP within 60 days of the accreditation body's adverse appeals decision, at the following address: Food and Drug Administration, Center for Devices and Radiological Health, Division of Mammography Quality and Radiation Programs, Attn: Facility Accreditation Review Committee, 10903 New Hampshire Ave., Bldg. 66, rm. 4521, Silver Spring, MD 20993-0002.

26. Section 900.18 is amended by revising paragraph (c) introductory text to read as follows:

§ 900.18

Alternative requirements for § 900.12 quality standards.

(c) Applications for approval of an alternative standard. An application for approval of an alternative standard or for an amendment or extension of the alternative standard shall be submitted in an original and two copies to the Food and Drug Administration, Center for Devices and Radiological Health, Director, Division of Mammography Quality and Radiation Programs, 10903 New Hampshire Ave., Bldg. 66, rm. 4521, Silver Spring, MD 20993-0002. The application for approval of an alternative standard shall include the following information:

27. Section 900.21 is amended by revising paragraph (b)(1) to read as follows:

§ 900.21

Application for approval as a certification agency.

(b) * * * (1) An applicant seeking FDA approval as a certification agency shall inform the Food and Drug Administration, Center for Devices and Radiological Health, Director, Division of Mammography Quality and Radiation Programs, Attn: States as Certifiers Coordinator, 10903 New Hampshire Ave., Bldg. 66, rm. 4521, Silver Spring, MD 20993-0002, in writing, of its desire to be approved as a certification agency.

PART 1002—RECORDS AND REPORTS

28. 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.

29. Section 1002.7 is amended by revising the introductory text to read as follows:

§ 1002.7

Submission of data and reports.

All submissions such as reports, test data, product descriptions, and other information required by this part, or voluntarily submitted to the Director, Center for Devices and Radiological Health, shall be filed with the number of copies as prescribed by the Director, Center for Devices and Radiological Health, and shall be signed by the person making the submission. The submissions required by this part shall be addressed to the Food and Drug Administration, Center for Devices and Radiological Health, ATTN: Electronic Product Reports, Document Mail Center, 10903 New Hampshire Ave., Bldg. 66, rm. G609, Silver Spring, MD 20993-0002.

30. Section 1002.10 is amended by revising the introductory text to read as follows:

§ 1002.10

Product reports.

Every manufacturer of a product or component requiring a product report as set forth in table 1 of § 1002.1 shall submit a product report to the Food and Drug Administration, Center for Devices and Radiological Health, ATTN: Electronic Product Reports, Document Mail Center, 10903 New Hampshire Ave., Bldg. 66, rm. G609, Silver Spring, MD 20993-0002, prior to the introduction of such product into commerce. The report shall be distinctly marked “Radiation Safety Product Report of (name of manufacturer)” and shall:

31. Section 1002.20 is amended by revising paragraph (b) introductory text to read as follows:

§ 1002.20

Reporting of accidental radiation occurrences.

(b) Such reports shall be addressed to Food and Drug Administration, Center for Devices and Radiological Health, ATTN: Accidental Radiation Occurrence Reports, Document Mail Center, 10903 New Hampshire Ave., Bldg. 66, rm. G609, Silver Spring, MD 20993-0002, and the reports and their envelopes shall be distinctly marked “Report on 1002.20” and shall contain all of the following information where known to the manufacturer:

32. Section 1002.50 is amended by revising paragraph (c)(3) to read as follows:

§ 1002.50

Special exemptions.

(c) * * *

(3) Such conditions as are deemed necessary to protect the public health and safety. Copies of exemptions shall be available upon request from the Food and Drug Administration, Center for Devices and Radiological Health, Division of Mammography Quality and Radiation Programs, 10903 New Hampshire Ave., Bldg. 66, rm. 4521, Silver Spring, MD 20993-0002.

PART 1040—PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS

33. The authority citation for 21 CFR part 1040 continues to read as follows:

Authority: 21 U.S.C. 351, 352, 360, 360e-360j, 371, 381; 42 U.S.C. 263B-263n.

34. Section 1040.10 is amended by revising paragraph (a)(3)(i) to read as follows:

§ 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 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.

35. Section 1040.20 is amended by revising paragraph (d)(3)(iii) to read as follows:

§ 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, 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, 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.

Dated: April 12, 2010.

Leslie Kux,

Acting Assistant Commissioner for Policy.