[Federal Register Volume 65, Number 63 (Friday, March 31, 2000)]
[Rules and Regulations]
[Pages 17136-17138]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-8038]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 803, 807, 812, 814, 860, 1005, 1010, 1020, and 1040

[Docket No. 00N-0784]


Medical Devices; Information Processing Procedures; Obtaining, 
Submitting, Executing, and Filing of Forms: Change of Addresses

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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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 addresses in the agency. All 
filings and other documents subject to these regulations must be 
directed to the new address. This action is being taken to ensure the 
accuracy of FDA's regulations.

DATES: This rule is effective March 31, 2000.

FOR FURTHER INFORMATION CONTACT: Domini H. Cassis, Center for Devices 
and Radiological Health (HFZ-215), Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850, 301-827-2964.

SUPPLEMENTARY INFORMATION: This rule reflects the relocation of certain 
component offices within the agency that are responsible for processing 
documents relating to medical devices. This administrative action is 
limited to changing specific addresses for obtaining, submitting, 
executing, and filing certain documents, but it makes no other changes 
in filing requirements.
    This document is published as a final rule with the effective date 
shown above. Because the final rule is an administrative action to 
update addresses for certain agency offices, FDA has determined that it 
has no substantive impact on the public. It imposes no costs, and 
merely updates a list of addresses included in the Code of Federal 
Regulations (CFR) for the convenience of the public. FDA, therefore, 
for good cause, finds under 5 U.S.C. 553(b)(3)(B) and (d)(3) that 
notice and public comment are unnecessary and that this rule may take 
effect upon publication.

List of Subjects

21 CFR Part 803

    Imports, Medical devices, 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 Part 860

    Administrative practice and procedure, Medical devices.

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 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 
parts 803, 807, 812, 814, 860, 1005, 1010, 1020, and 1040 are amended 
as follows:

PART 803--MEDICAL DEVICE REPORTING

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

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

    2. Section 803.11 is revised to read as follows:


Sec. 803.11  Obtaining the forms.

    User facilities and manufacturers must submit all reports of 
individual adverse events on FDA Form 3500A (MEDWATCH form) or in an 
electronic equivalent as approved under Sec. 803.14. This form and all 
other forms referenced in this section can also be obtained from the 
Consolidated Forms and Publications Office, Washington

[[Page 17137]]

Commerce Center, 3222 Hubbard Rd., Landover, MD 20875; from the Food 
and Drug Administration, MEDWATCH (HF-2), 5600 Fishers Lane, Rockville, 
MD 20857, 301-827-7240; from the Division of Small Manufacturers 
Assistance, Office of Health and Industry Programs, Center for Devices 
and Radiological Health (HFZ-220), 1350 Piccard Dr. Rockville, MD 
20850, FAX 301-443-8818; or from http://www.fda.gov/opacom/morechoices/fdaforms/cdrh.html on the Internet.

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

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

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

    4. Section 807.90 is amended by revising paragraphs (a)(1) and 
(a)(2) 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 (HFZ-401), 9200 Corporate 
Blvd., Rockville, MD 20850.
    (2) For devices regulated by the Center for Biologics Evaluation 
and Research, be addressed to the Food and Drug Administration, Center 
for Biologics Evaluation and Research, Document Control Room (HFM-99), 
1401 Rockville Pike, Rockville, MD 20852-1448. Information about 
devices regulated by the Center for Biologics Evaluation and Research 
is available at http://www.fda.gov/cber/dap/devlst.htm on the Internet.
* * * * *

PART 812--INVESTIGATIONAL DEVICE EXEMPTIONS

    5. 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.

    6. Section 812.19 is revised to read as follows:


Sec. 812.19  Address for IDE correspondence.

    If you are sending an application, supplemental application, 
report, request for waiver, request for import or export approval, or 
other correspondence relating to matters covered by this part, you must 
address it to the Center for Devices and Radiological Health, Document 
Mail Center (HFZ-401), Food and Drug Administration, 9200 Corporate 
Blvd., Rockville, MD 20850. You must state on the outside wrapper of 
each submission what the submission is, for example, an ``IDE 
application,'' a ``supplemental IDE application,'' or a 
``correspondence concerning an IDE (or an IDE application).''

PART 814--PREMARKET APPROVAL OF MEDICAL DEVICES

    7. 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.

    8. Section 814.20 is amended by revising paragraphs (g) and (h) to 
read as follows:


Sec. 814.20  Application.

* * * * *
    (g) FDA has issued a PMA guideline to assist the applicant in the 
arrangement and content of a PMA. This guideline is available upon 
request from the Center for Devices and Radiological Health, Division 
of Small Manufacturers Assistance (HFZ-220), 1350 Piccard Dr. 
Rockville, MD 20850, FAX 301-443-8818.
    (h) If you are sending a PMA, PMA amendment, PMA supplement, or 
correspondence with respect to a PMA, you must send it to the Document 
Mail Center (HFZ-401), Center for Devices and Radiological Health, Food 
and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850.

PART 860--MEDICAL DEVICE CLASSIFICATION PROCEDURES

    9. 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.

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


Sec. 860.123  Reclassification petition: Content and form.

* * * * *
    (b) * * *
    (1) Addressed to the Food and Drug Administration, Center for 
Devices and Radiological Health, Regulations Staff (HFZ-215), 1350 
Piccard Dr., Rockville, MD 20850;
* * * * *

PART 1005--IMPORTATION OF ELECTRONIC PRODUCTS

    11. The authority citation for 21 CFR part 1005 continues to read 
as follows:

    Authority: 42 U.S.C. 263d, 263h.

    12. Section 1005.25 is amended by revising paragraph (b) to read as 
follows:


Sec. 1005.25  Service of process on manufacturers.

* * * * *
    (b) A manufacturer designating an agent must address the 
designation to the Center for Devices and Radiological Health, 9200 
Corporate Blvd., Rockville, MD 20850. It must be in writing and dated; 
all signatures must be in ink. The designation must be made in the 
legal form required to make it valid and binding on the manufacturer 
under the laws, corporate bylaws, or other requirements governing the 
making of the designation by the manufacturer at the place and time 
where it is made, and the persons or person signing the designation 
shall certify that it is so made. The designation must disclose the 
manufacturer's full legal name and the name(s) under which the 
manufacturer conducts the business, if applicable, the principal place 
of business, and mailing address. If any of the products of the 
manufacturer do not bear his legal name, the designation must identify 
the marks, trade names, or other designations of origin which these 
products bear. The designation must provide that it will remain in 
effect until withdrawn or replaced by the manufacturer and shall bear a 
declaration of acceptance duly signed by the designated agent. The full 
legal name and mailing address of the agent must be stated. Until 
rejected by the Secretary, designations are binding on the manufacturer 
even when not in compliance with all the requirements of this section. 
The designated agent may not assign performance of his function under 
the designation to another.
* * * * *

PART 1010--PERFORMANCE STANDARDS FOR ELECTRONIC PRODUCTS: GENERAL

    13. The authority citation for 21 CFR part 1010 continues to read 
as follows:

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

    14. Section 1010.4 is amended by revising paragraph (b) to read as 
follows:


Sec. 1010.4  Variances.

* * * * *
    (b) Applications for variances. If you are submitting an 
application for variances or for amendments or

[[Page 17138]]

extensions thereof, you must submit an original and two copies to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852.
* * * * *
    15. Section 1010.5 is amended by revising paragraph (c) to read as 
follows:


Sec. 1010.5  Exemptions for products intended for United States 
Government use.

* * * * *
    (c) Application for exemption. If you are submitting an application 
for exemption, or for amendment or extension thereof, you must submit 
an original and two copies to the Dockets Management Branch (HFA-305), 
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852. For an exemption under the criteria prescribed in paragraph 
(a)(1) of this section, the application shall include the information 
prescribed in paragraphs (c)(1) through (c)(13) of this section. For an 
exemption under the criteria prescribed in paragraph (a)(2) of this 
section, the application shall include the information prescribed in 
paragraphs (c)(3) through (c)(13) of this section. An application for 
exemption, or for amendment or extension thereof, and correspondence 
relating to such application shall be made available for public 
disclosure in the Dockets Management Branch, except for confidential or 
proprietary information submitted in accordance with part 20 of this 
chapter. Information classified for reasons of national security shall 
not be included in the application. Except as indicated in this 
paragraph, the application for exemption shall include the following:
* * * * *

PART 1020--PERFORMANCE STANDARDS FOR IONIZING RADIATION EMITTING 
PRODUCTS

    16. The authority citation for 21 CFR part 1020 continues to read 
as follows:

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

    17. Section 1020.30 is amended by revising paragraph (d)(1) to read 
as follows:


Sec. 1020.30  Diagnostic x-ray systems and their major components.

* * * * *
    (d) * * *
    (1) Reports of assembly. All assemblers who install certified 
components shall file a report of assembly, except as specified in 
paragraph (d)(2) of this section. The report will be construed as the 
assembler's certification and identification under Secs. 1010.2 and 
1010.3 of this chapter. The assembler shall affirm in the report that 
the manufacturer's instructions were followed in the assembly or that 
the certified components as assembled into the system meet all 
applicable requirements of Secs. 1020.30 through 1020.33. All assembler 
reports must be on a form prescribed by and available from the 
Director, Center for Devices and Radiological Health, 9200 Corporate 
Blvd., Rockville, MD 20850. Completed reports must be submitted to the 
Director, the purchaser, and, where applicable, to the State agency 
responsible for radiation protection within 15 days following 
completion of the assembly.
* * * * *

PART 1040--PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS

    18. 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.

    19. 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 Director, Office of Compliance (HFZ-300), Center for Devices and 
Radiological Health, 2094 Gaither Rd., Rockville, MD 20850.
* * * * *

    Dated: March 22, 2000.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 00-8038 Filed 3-30-00; 8:45 am]
BILLING CODE 4160-01-F