Regulatory Focus™ > News Articles > FDA: 99% of Establishment Registrations Now Electronic Post-FDAAA

FDA: 99% of Establishment Registrations Now Electronic Post-FDAAA

Posted 13 January 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) is reporting today via the Federal Register that the overwhelming majority of establishment registrations are now taking place electronically, including initial establishment registrations, foreign registrations and annual registrations.

The Food and Drug Administration Amendments Act of 2007 (FDAAA) includes sections 222, 223 and 224, which regulate the registration of establishments under Section 510 of the Federal Food, Drug and Cosmetic Act (FD&C Act). FDAAA mandated that these registrations now occur electronically unless a waiver is granted if electronic registration is "not reasonable." This waiver exemption is contained under Section 224 of FDAAA.

Section 222 of FDAAA requires that domestic establishments register annually between 1 October and 31 December, and that foreign establishments register as soon as one of its products is covered by the FD&C Act. Section 223 requires establishments list devices that they manufacture with FDA on an annual basis between 1 October and 31 December.

As of September of 2011, more than 24,000 establishments had registered electronically. FDA noted that requests for waivers amounted to less than one percent of total registrations. In 2007, for example, the agency received only ten waiver requests despite receiving more than 16,000 electronic registrations. According to FDA this number has remained consistently below 1% since 2007.

FDA now has more than 24,000 device establishments registered by more than 21,200 owners and operators. The fee to register an establishment in FY2012 is $2,029.

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