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FDA医疗器械监管部门CDRH启动搬迁和网站更新计划

IRC资讯，FDA负责对医疗器械监管的具体部门Center for Devices and Radiological Health (CDRH)于2009年5月15日启动搬迁计划，新址位于FDA White Oak campus located in Silver Spring, MD，本次搬迁计划将在2009年8月3日结束。

本次变迁中全球所有与FDA CDRH的联系建议以电子邮件为主，电话，传真等将在此期间每周更新和发布；

与医疗器械厂商相关的510(K)申请将在2009年5月中旬到8月初期间内，每周五和每周一这两个工作日，FDA将暂时不受理收到的510(K)申请；

相关申请受理时间和联系地址如下：

http://www.fda.gov/cdrh/ode/subadd.html

Addresses for Submissions

For all CDRH ODE and OIVD submissions: 510(k), IDE, PMA, 513(g), Pre-IDE, PDP, HDE and CLIA:

The Document Mail Center will continue to accept regulatory documents at the following address until 4:30 on July 31, 2009.

U.S. Food and Drug Administration
Center for Devices and Radiological Heath
Document Mail Center - HFZ-401
9200 Corporate Boulevard
Rockville , MD  20850

Documents that are to be received August 3, 2009 and after must be sent to the following address:

U.S. Food and Drug Administration
Center for Devices and Radiological Heath
Document Mail Center – WO66 Room 0609
10903 New Hampshire Avenue
Silver Spring , MD  20993-0002

Deliveries are accepted between the hours of 8:00 to 4:30 EST.

For all CDRH OC Registration and Listing submissions:

FDA Center for Devices and Radiological Health
Registration and Listing, HFZ-308
9200 Corporate Boulevard
Rockville, MD 20850

For all CDRH Medwatch submissions:

FDA Center for Devices and Radiological Health
Medical Device Reporting (Medwatch), HFZ-535
9200 Corporate Boulevard
Rockville, MD 20850

For Small Business Determinations:  

MDUFMA Small Business Qualification (HFZ-222)
Division of Small Manufacturers, International and Consumer Assistance (DSMICA)
1350 Piccard Drive
Rockville, MD  20850 

For all medical device Export Certificate requests:

Food and Drug Administration
Center for Devices and Radiological Health
Office of Compliance
Attention: HFZ-307
9200 Corporate Blvd.
Rockville, MD 20850

For consumer questions or manufacturers assistance, please contact DSMICA at http://www.fda.gov/cdrh/devadvice/36f.html.

伴随着FDA CDRH部门的搬迁，FDA CDRH网站用户界面也将作出重大更新，从2009年5月29日后，请通过下面的链接访问新的CDRH网站：

http://www.fda.gov/MedicalDevices/default.htm

IRC编译整理

www.FDAChina.com