OIVD Decision Summaries for Products Cleared or Approved Since November 2003

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OIVD Decision Summaries are compilations of the information used to clear or approve IVD 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 available for all home and lab tests that have been cleared or approved since November 2003.

Decision Summaries are attached to entries in FDA’s IVD database. To find a Decision Summary for a particular product,

1. go to FDA’s IVD database
2. enter a search term (for example the type of test, name, company, or other key word) in the blank space
3. click on “Search”
4. review the listing of products that match your search term
5. select a product from the list
6. scroll through the Device Summary Information for the entry marked Decision Summary

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