Tools

RAMS gives users free access to its 501(k) Review Time calculator, FDA Product Classification Lookup and Government Fee Finder tools.

510(k) Review Time Calculator:

Real-time integration with the FDA allows you to calculate, how many calendar days, historically it has taken for a 510(k) to be cleared by the US FDA.

Estimate the time needed to secure FDA 510(k) clearance based on the type of product.

Information derived from publicly available data through open FDA.

To Access the 501(k) Review Time Calculator:

  1. Click "Resources" 
  2. Click "Tools"

FDA Product Classification Lookup tool:

Helps you understand what requirements apply to your device.

To Access the FDA Product Classification Lookup tool:

  1. Click "Resources"
  2. Click "Tools"

Government Fee Finder:

Government Fee Finder identifies government filing costs when expanding into new markets or while renewing for existing business. 

To access the Government Fee Finder you may use the below path:

  1. Go to Resources -> Tools -> Government Fee Finder
  2. Click Check it out to open the tool
  3. From the drop down select your filter values:
    • Country, Device Type & Fee Type 
  4. Click Search to view all applicable related fees

5. The last date the fee was updated is also available at the end of the tabulated search