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Resource Library for Medical Device Professionals

5 total results. Show all resources.
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United States

Get smart about the USA in 1 hour

Thinking about entering the US market for the first time? Understanding the FDA regulatory requirements can be overwhelming and confusing. We assembled a packet that includes the basic information you need before deciding to enter the US market.

1 page
May 1, 2017
How long does it take the FDA to clear 510(k) submissions? We look at 5 years of data to identify trends.
United States

How long it takes the US FDA to approve 510(k) submissions

How long does it take the FDA to clear 510(k) submissions? We look at 5 years of data to identify trends.

11 pages
Feb 1, 2013
Learn about basic demographic and healthcare market data on the United States
United States

USA – Overview of medical device industry and healthcare statistics

A brief look at the United States' medical device market, including potential opportunities and obstacles for manufacturers.

1 web page
Oct 18, 2013
United States

FDA - US Food and Drug Administration

Learn about the regulatory structure in the United States and major medical device regulations.

1 page
Feb 10, 2014
United States

What is a 510(k)?

Learn about the FDA 510(k) process in this informative page from Emergo

1 page
Jun 23, 2017