FDA Establishment Registration Process

FDA Establishment Registration Process

Recently the U.S. Food and Drug Administration (FDA) announced that it was extending the period for completing establishment registration by one month, from December 31, 2012 to January 31, 2013. In addition, it announced that as of December 17, 2012 the FURLS web-based system used for completing the establishment registration will be enhanced to allow for the following:

  1. the use of an uploadable spreadsheet to identify importers of foreign-produced medical devices; and,
  2. the use of an uploadable spreadsheet to identify proprietary names of an establishment's listed devices.

Also, by the end of December, FURLS will be upgraded to facilitate the following additional functionality:

  1. the ability to list medical devices being offered for sale into the U.S., but which currently are not being shipped to the U.S.; and,
  2. the ability of foreign companies that do not sell directly into the U.S. market, but rather sell through foreign-based middlemen or distributors who in turn export to the U.S., to identify those middlemen or distributors. These middlemen or distributors must register with the FDA as foreign exporters.

The FDA's recent memo makes the additional point that the turn-around time on questions posed to it about the registration process is running between five to ten business days. So, give the agency at least two weeks to respond before reaching out to it again.

Members with questions on these topics can contact Rick Van Arnam, The Vision Council's regulatory counsel, at rvanarnam@barnesrichardson.com.