FDA Move to new Quarters – 510(k) submissions will have some delays.

The FDA has made a move to new quarters and there will be some delays in 510(k) submission log in. See below the FDA notice. The move actually just took place and there are some problems in getting to reach the FDA because of all the confusion.

We’re Moving!

CDRH is moving to the FDA White Oak Campus in
Silver Spring, Maryland
Between May 15 and August 3, 2009

The Center for Devices and Radiological Health (CDRH) will be relocating to the FDA White Oak campus located at 10903 New Hampshire Avenue, Silver Spring, MD 20993 this summer. The Center will begin moving May 15, 2009, and all staff should be located at the new campus by August 3, 2009. During this time, the best way to reach CDRH staff is by e-mail, because all office addresses, phone and fax numbers will change.

Each week we will update the list of current addresses and phone numbers. You can use this list to find contact information for each CDRH office:

• Current CDRH phone numbers and addresses (effective July 13, 2009)
After employees move, their current phone numbers will have messages providing new phone numbers for 30 days.

Temporary Deferment of Activities Relating to Medical Device Submissions

During the period of mid-May 2009 until the beginning of August 2009, the Center for Devices and Radiological Health will not officially receive premarket submissions on Friday’s and Monday’s.

For more information on this article, please email mdi at info@mdiconsultants.com and reference FDA move.