 |
Wellkang® LLC |
World Leading Consultancy in
FDA 510(k), UL, CCC Mark, CE Marking |
|
|
| |
Your One-Stop Reliable Partner in International Trade! |
|
Search: |
|
|
|
|
|
|
510(k) Submission Process |
|
|
|
News - “US Agent” Needed |
|
|
| |
February 11, 2002:
The FDA requires that all non-US medical device manufacturers wishing to market their products in the United States must have a local representative in the US, i.e. the “US Agent”.
Wellkang LLC is your reliable “US Agent” in dealing with FDA.
|
|
|
|
| |
Step 3: Reviewer Assignment
Several things can affect how quickly 510(k)s are reviewed, such as:
- IDEs and PMAs have statutory due dates and therefore take priority over 510(k)s;
- 510(k)s and PMAs granted expedited review are taken out of turn and reviewed first;
- If additional data is requested from FDA by letter, the application is put on hold; and
- Consulting review of 510(k)s by another CDRH office or another FDA Center.
Click here to continue...
|
|
|
|
|
|
|
