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Resource Library for Medical Device Professionals

3 total results. Show all resources.
Our 510(k) calculator looks how long it has taken the FDA to clear specific devices during the past five years.
United States

How Long Will It Take My 510(k) to be Cleared by the FDA?

Use this calculator to see how many calendar days it usually takes the US FDA to clear medical devices with the same Product Code.

Interactive Calculator
Mar 19, 2014
Download the Chart on the Medical Device Approval Process in the USA
United States

US FDA Registration Process for Medical Devices

This chart illustrates the steps in the US FDA's medical device approval process and includes a timeline of expected approval.

2 pages
Jan 1, 2015
Compare the time, cost and complexity of getting regulatory approval for medical devices
United States

Time, Cost and Complexity of Regulatory Approvals Worldwide

Use this interactive table to estimate how long it takes to gain approval in popular markets worldwide, along with associated costs.

Interactive Page
Aug 25, 2015