Document ID: FDA-2009-N-0210-0001
Agency: fda
Document Type: Notice
Title: Temporary Deferment of Activities Relating to Medical Device Submissions
Posted Date: 2009-05-21T04:00Z

[Federal Register: May 21, 2009 (Volume 74, Number 97)]
[Notices]               
[Page 23874]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21my09-66]                         

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0210]

 
Temporary Deferment of Activities Relating to Medical Device 
Submissions

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
Center for Devices and Radiological Health (CDRH) will be moving from 
various Rockville, Maryland locations to Building 66 at 10903 New 
Hampshire Avenue in Silver Spring, Maryland from approximately mid May 
2009 until the beginning of August 2009. Offices will progressively 
move over weekends during this period. Specifically, moves will occur 
on Friday, Saturday, and Sunday except on holiday weekends. During the 
period required for relocation of files, equipment, and agency 
personnel, the Center for Devices and Radiological Health will not 
officially receive premarket submissions on the Friday of a move 
weekend and the Monday after a move weekend.

FOR FURTHER INFORMATION CONTACT: Marjorie Shulman, Center for Devices 
and Radiological Health (HFZ-404), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 240-276-4186 or 
Marjorie.shulman@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    CDRH is responsible for activities under sections 510, 513, 515, 
and 520 of the Federal Food, Drug, and Cosmetic Act (the act) (21 
U.S.C. 360, 360c, 360e, and 360j). These activities include, but are 
not limited to:
    1. Advising the Director, CDRH, and other FDA officials on all 
medical device submissions, such as premarket notification submissions 
under section 510(k) of the act, device classifications under section 
513 of the act, premarket approval applications (PMA's) and product 
development protocols (PDP's) under section 515 of the act, and 
clinical investigations under section 520 of the act;
    2. Determining substantial equivalence for premarket notification 
submissions;
    3. Planning, conducting, and coordinating CDRH actions regarding 
PMA's, PDP's, and investigational device exemption approvals, denials, 
or withdrawals of approval;
    4. Monitoring sponsors' compliance with regulatory requirements; 
and
    5. Conducting a continuing review, surveillance, and medical 
evaluation of the labeling, clinical experience, and required reports 
submitted by sponsors holding approved applications.
    In an effort to consolidate CDRH offices, FDA is moving various 
CDRH offices from their present Rockville, Maryland locations to 
Building 66 at 10903 New Hampshire Avenue in Silver Spring, Maryland. 
Offices will progressively move, during weekends, during this period. 
Specifically, moves will occur on Friday, Saturday, and Sunday except 
on holiday weekends. During the period required for relocation of 
files, equipment, and agency personnel, the agency, specifically the 
Center for Devices and Radiological Health, will not officially receive 
submissions on the Friday of a move weekend and the Monday after a move 
weekend. Although mail will be delivered to a CDRH address during the 
move, CDRH will not be able to receive it on Fridays and Mondays, and 
will have limited capacity on Tuesday. Accordingly, mail delivered on 
Friday or Monday will be logged in on a staggered basis to preserve 
equity in the order of receipt and manageability of the accumulated 
workload. Specifically, mail delivered on Friday or Monday will be 
received on Tuesday and mail delivered on Tuesday will be received by 
Wednesday. Mail delivered on Wednesdays and Thursdays will remain 
unaffected.
    The new mailing address for submissions and updated telephone 
contact information may be found by accessing www.fda.gov/cdrh/
whiteoakmove.

II. Comments

    Persons who may be affected by this temporary deferment should 
contact FDA with any questions they may have regarding CDRH's move to 
the White Oak, Maryland. These persons should call CDRH's Division of 
Small Manufacturers, International, and Consumer Assistance at 800-638-
2041 (in Maryland, 240-276-3150).

    Dated: May 13, 2009.
Daniel G. Schultz,
Director, Center for Devices and Radiological Health.

[FR Doc. E9-11840 Filed 5-20-09; 8:45 am]

BILLING CODE 4160-01-S