Contact Us
OIVD wants to hear from you. Use this page to comment about this
website, to report problems you are having with IVD products, or to
ask us a question.
|
| |
Address: |
HFZ-440
2098 Gaither Road
Rockville, MD 20850 |
| |
Phone Number: |
(240) 276-0450 |
| |
Fax Number: |
(240) 276-0643 |
|
| |
- Address for Document Submission
|
Food and Drug Administration
Center for Devices and Radiological Health
510(k) Document Mail Center (HFZ-401)
9200 Corporate Boulevard
Rockville, Maryland 20850
|
| |
- Questions about evaluating the complexity of laboratory tests:
|
 |
CLIA Coordinator
Office of In Vitro Diagnostic Device Evaluation and Safety (HFZ-440)
2098 Gaither Road
Rockville, Maryland 20850
e-mail (CLIA@CDRH.FDA.GOV). |
|
| |
- Reporting a problem with a test kit or other IVD product:
|
Mandatory Reporting by User Facilities (MDR)
Voluntary Reporting by Consumers (MedWatch)
Voluntary Reporting by Healthcare Professionals (MedWatch)
|
| |
|
Use the form below to email your questions, comments, or problems associated with IVD products. You do not need to enter your name or email address unless you would like to receive a response. If you would like to contact us directly, send email to FDAlabtest@cdrh.fda.gov.
Privacy Notice
|
|
