FDA Requires E-Filing Effective October 1st

October 19, 2007

Effective October 1, 2007 the FDA converted the process by which companies file initial establishment registrations, annual registration renewals and device listings with the agency from a paper filing to an e-filing.  If a company has an existing establishment registration on file with the FDA, then it should have received a letter from the FDA to this effect.  If it did not get one, then it should check with its official correspondent, as the letter would have been sent to that person.  The highlights of the change are below:

1. For those companies that already have an establishment registration on file with the FDA, from now on the annual registration required to keep in good standing with the FDA MUST BE filed between October 1^st and December 31^st of each year.  All registration for 2008 MUST BE done before the end of this year.
2. However, because of problems on the FDA website, the FDA is advising that companies wait until after October 30^th of this year before updating their registration information for 2008.  Any new registration, however, can be made now via e-filing.
3. These registrations must be done electronically.  If you received a letter from the FDA because you are currently shown in the FDA’s system as being a registered establishment, then that letter gives the web address and company’s account identification and password.  If a letter was not forwarded, then go to www.fda.gov/cdrh/reglistpage.html and follow the prompts to get a user identification and password.
4. If the password issued in the letter from the FDA has fewer than 8 characters it will not work.  Contact the FDA at reglist@cdrh.fda.gov for assistance.
5. FEES – Certain classes of establishment registrations will now be required to pay an annual fee.  The fee for 2008 is $1,706.00.  The following classes, both foreign and domestic, must pay this fee:

a.         Device manufacturers                

b.         Specification Developer

c.         Contract sterilizers                    

d.         Single-use device reprocessor

e.         Contract manufactures

6.  Follow the directions on the web site for making payment.  Make sure to allow at least 2 weeks for the payment to be recorded.  Registration will not be complete until the FDA advises you so.