Our organizational Structure
US Parent Entity -Sponsor
Indian Subsidiary(wholly owned by US parent entity) -Manufacturer
We are a newly established business planning to submit a 510(k) application to the FDA, we want to ensure we follow the correct steps. We have outlined the process as follows:
Step 1: Register our US Parent entity with the FDA as a small business entity.
Step 2: Pay the required 510(k) user fee through DFUF website.
Step 3: Create an FURLS account(OAA) for US entity.
Step 4: Submit the 510(k) application using the CDRH portal.
However, we're unsure if we need to pay both the annual establishment registration fee and the 510(k) submission fee since we don't have products in distribution in the US.
1.Is FDA annual establishment registration fee mandatory for US entity without products in distribution when submitting a 510(k) application ?
2.For FURLS account, should we register US entity ,on behalf of the manufacturer(Indian Subsidiary)?
3.Is it mandatory to create FURLS account for 510K submission?
US Parent Entity -Sponsor
Indian Subsidiary(wholly owned by US parent entity) -Manufacturer
We are a newly established business planning to submit a 510(k) application to the FDA, we want to ensure we follow the correct steps. We have outlined the process as follows:
Step 1: Register our US Parent entity with the FDA as a small business entity.
Step 2: Pay the required 510(k) user fee through DFUF website.
Step 3: Create an FURLS account(OAA) for US entity.
Step 4: Submit the 510(k) application using the CDRH portal.
However, we're unsure if we need to pay both the annual establishment registration fee and the 510(k) submission fee since we don't have products in distribution in the US.
1.Is FDA annual establishment registration fee mandatory for US entity without products in distribution when submitting a 510(k) application ?
2.For FURLS account, should we register US entity ,on behalf of the manufacturer(Indian Subsidiary)?
3.Is it mandatory to create FURLS account for 510K submission?
