This database search obtains information on all In Vitro Diagnostic Devices cleared or approved since November 2003. Many of the products in this database have Decision Summaries, from which you can get the information OIVD used to clear or approve the products.
Each Decision Summary contains:
- a review of the data submitted by an applicant to support a PMA or 510(k) application, and
- FDA’s justification in approving or clearing the product.
You can use Decision Summaries to:
- see what types of clinical studies other applicants conducted so that you can conduct similar studies
- learn how FDA reviewed an applicant’s data to grant approval or substantial equivalence
- find out how thoroughly an applicant studied a particular product before it was submitted to FDA
Decision Summaries are attached to entries in FDA’s In Vitro Diagnostic Product Database. To find a Decision Summary for a particular product,
- go to link nearby for FDA’s In Vitro Diagnostic Product Database
- enter a search term (for example the type of test, name, company, or other key word) in the blank space
- click on “Search”
- review the listing of products that match your search term
- select a product from the list
- scroll through the Device Summary Information for the entry marked Decision Summary