Quick Tip: FDA's 510k database is a treasure trove of information for medical devices
Learn how to use FDAs searchable 510k database to gather information relevant for your own medical device even if you don't plan to market in the USA.
A vast majority of medical devices in the United States are cleared by the US FDA through the 510(k) regulatory pathway. Chances are, there is a very similar device already in the market with a lot of relevant information you can access through FDA’s searchable 510(k) database.
Here is how this information can be useful, even if you don’t intend to market your device in the United States.
As risk practitioners, we are interested in learning about safety and effectiveness of a medical device. Publicly available information from a regulatory agency such as the FDA is the most reliable source for this purpose.
Information available from the searchable 510(k) database can be useful as a starting point to understand the regulatory history of a specific medical device. Here are a few examples of how this information can be used:
Finding a predicate device for a new medical device under development based on similar intended use.
FDA regulations and product classification codes that may be relevant for a new medical device.
Comparison of technological characteristics and type of testing done to support the claim of substantial equivalence.
History of changes in a specific medical device.
History of regulatory actions such as recalls.
Check out the article below for step-by-step directions for searching the database and gathering useful information.
