[Federal Register Volume 75, Number 77 (Thursday, April 22, 2010)]
[Rules and Regulations]
[Pages 20913-20917]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-8863]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 1, 801, 803, 807, 812, 814, 820, 822, 860, 900, 1002,
and 1040
[Docket No. FDA-2010-N-0010]
Center for Devices and Radiological Health; New Address
Information
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendments.
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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.
[[Page 20914]]
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.
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 1--GENERAL ENFORCEMENT REGULATIONS
0
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.
0
2. Section 1.101 is amended by revising paragraph (d)(2)(iii) to read
as follows:
Sec. 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
0
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.
0
4. Section 801.430 is amended by revising the text of footnote number 1
in paragraph (f)(2) to read as follows:
Sec. 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
0
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.
0
6. Section 803.11 is amended by revising paragraph (c) to read as
follows:
Sec. 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.
* * * * *
0
7. Section 803.21 is amended by revising paragraph (a) to read as
follows:
Sec. 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
0
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.
0
9. Section 807.22 is amended by revising paragraph (a) to read as
follows:
Sec. 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
Sec. 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 Sec. 807.21(a). The completed form shall be
mailed to the address designated in this paragraph 30 days after
receipt from FDA.
* * * * *
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10. Section 807.37 is amended by revising paragraphs (a) and (b)(2) to
read as follows:
Sec. 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
[[Page 20915]]
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.
* * * * *
0
11. Section 807.90 is amended by revising paragraph (a)(1) to read as
follows:
Sec. 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
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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.
0
13. Section 812.19 is amended by revising paragraph (a)(1) to read as
follows:
Sec. 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
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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.
0
15. Section 814.20 is amended by revising paragraph (h)(1) to read as
follows:
Sec. 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.
* * * * *
0
16. Section 814.104 is amended by revising paragraph (d)(1) to read as
follows:
Sec. 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
0
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.
0
18. Section 820.1 is amended by revising paragraph (e)(1) to read as
follows:
Sec. 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 Sec. 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: 301-847-8149.
* * * * *
PART 822--POSTMARKET SURVEILLANCE
0
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.
0
20. Section 822.8 is revised to read as follows:
Sec. 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.
0
21. Section 822.12 is revised to read as follows:
Sec. 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
[[Page 20916]]
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
0
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.
0
23. Section 860.123 is amended by revising paragraph (b)(1) to read as
follows:
Sec. 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
0
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.
0
25. Section 900.15 is amended by revising paragraph (d)(3)(i) to read
as follows:
Sec. 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.
* * * * *
0
26. Section 900.18 is amended by revising paragraph (c) introductory
text to read as follows:
Sec. 900.18 Alternative requirements for Sec. 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:
* * * * *
0
27. Section 900.21 is amended by revising paragraph (b)(1) to read as
follows:
Sec. 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
0
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.
0
29. Section 1002.7 is amended by revising the introductory text to read
as follows:
Sec. 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.
* * * * *
0
30. Section 1002.10 is amended by revising the introductory text to
read as follows:
Sec. 1002.10 Product reports.
Every manufacturer of a product or component requiring a product
report as set forth in table 1 of Sec. 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:
* * * * *
0
31. Section 1002.20 is amended by revising paragraph (b) introductory
text to read as follows:
Sec. 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:
* * * * *
0
32. Section 1002.50 is amended by revising paragraph (c)(3) to read as
follows:
Sec. 1002.50 Special exemptions.
* * * * *
(c) * * *
(3) Such conditions as are deemed necessary to protect the public
health and safety. Copies of exemptions shall
[[Page 20917]]
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
0
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.
0
34. Section 1040.10 is amended by revising paragraph (a)(3)(i) 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 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.
* * * * *
0
35. Section 1040.20 is amended by revising paragraph (d)(3)(iii) 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, 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.
[FR Doc. 2010-8863 Filed 4-21-10; 8:45 am]
BILLING CODE 4160-01-S