E9-11840. 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 [e-mail].

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.