Medical Device Regulations; Addresses; Technical Amendment, 42048 [E6-11777]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 71, Number 142 (Tuesday, July 25, 2006)]
[Rules and Regulations]
[Page 42048]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-11777]



[[Page 42048]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 812 and 814

[Docket No. 2006N-0284]


Medical Device Regulations; Addresses; 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 
device regulations to include address information for the Center for 
Biologics Evaluation and Research and the Center for Drug Evaluation 
and Research. These regulations pertain to the submission of certain 
documents to FDA. Currently, only address information for the Center 
for Devices and Radiological Health is listed in these regulations. 
This action is being taken to ensure the accuracy of FDA's regulations.

DATES: This rule is effective July 25, 2006.

FOR FURTHER INFORMATION CONTACT: Stephen M. Ripley, Center for 
Biologics Evaluation and Research (HFM-17), Food and Drug 
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448, 301-827-6210.

SUPPLEMENTARY INFORMATION: FDA is amending its regulations in 21 CFR 
parts 812 and 814 to include address information for the Center for 
Biologics Evaluation and Research and the Center for Drug Evaluation 
and Research. These regulations pertain to the investigational device 
exemptions (IDEs) and premarket approval (PMA) of medical devices. 
Currently, only the address information for the Center for Devices and 
Radiological Health is listed in these regulations for the various 
submissions associated with IDE applications and PMA applications. IDEs 
and PMAs, and their associated submissions, must be sent to the address 
of the appropriate Center that has regulatory responsibility for the 
medical device. Therefore, FDA is updating its regulations to include 
this address information.
    Publication of this document constitutes final action under the 
Administrative Procedure Act (5 U.S.C. 553). FDA has determined that 
notice and public comment are unnecessary because this amendment to the 
regulations provides only a technical change to update addresses in the 
Code of Federal Regulations, and is nonsubstantive.

List of Subjects

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, and Reporting and 
recordkeeping requirements.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act, and Public 
Health Service Act, and under authority delegated to the Commissioner 
of Food and Drugs, 21 CFR parts 812 and 814 are amended as follows:

PART 812--INVESTIGATIONAL DEVICE EXEMPTIONS

0
1. 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
2. Section 812.19 is revised to read as follows:


Sec.  812.19  Address for IDE correspondence.

    (a) 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 
send the submission to the appropriate address as follows:
    (1) For devices regulated by the Center for Devices and 
Radiological Health, 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.
    (2) For devices regulated by the Center for Biologics Evaluation 
and Research, send it 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.
    (3) For devices regulated by the Center for Drug Evaluation and 
Research, send it to Central Document Control Room, Center for Drug 
Evaluation and Research, Food and Drug Administration, 5901-B Ammendale 
Rd., Beltsville, MD 20705-1266.
    (b) 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

0
3. 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
4. Section 814.20 is amended by revising paragraph (h) to read as 
follows:


Sec.  814.20  Application.

* * * * *
    (h) If you are sending a PMA, PMA amendment, PMA supplement, or 
correspondence with respect to a PMA, you must send the submission to 
the appropriate address as follows:
    (1) For devices regulated by the Center for Devices and 
Radiological Health, send it to: Document Mail Center (HFZ-401), Center 
for Devices and Radiological Health, Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850.
    (2) For devices regulated by the Center for Biologics Evaluation 
and Research, send it to: Document Control Center (HFM-99), Center for 
Biologics Evaluation and Research, Food and Drug Administration, 1401 
Rockville Pike, suite 200N, Rockville, MD 20852-1448.
    (3) For devices regulated by the Center for Drug Evaluation and 
Research, send it to: Central Document Control Room, Center for Drug 
Evaluation and Research, Food and Drug Administration, 5901-B Ammendale 
Rd., Beltsville, MD 20705-1266.

    Dated: July 17, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-11777 Filed 7-24-06; 8:45 am]
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