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View Full Version : FDA Annual Registration - Any harm to be FDA (form FDA 2891a) registrated Saaga 28th September 2005, 08:01 AM Hi there, Does anyone know if there is any harm to be FDA (form FDA 2891a)registrated even if you haven't the listed device at that time. Best Regards :confused: Al Rosen 28th September 2005, 10:28 AM Hi there, Does anyone know if there is any harm to be FDA (form FDA 2891a)registrated even if you haven't the listed device at that time. Best Regards :confused:Yes, unless you are a device establishment, you shouldn't register. The FDA has enough difficulty performing surveillance on legitimate establishments. BTW the correct form is 2891, Form 2891a is the form the FDA sends out for yearly registration updates. So unless you fall into one of the categories of who must register (http://www.fda.gov/cdrh/registration/whomust.html), you can't. BTW, if you are planning to go into production within 3 months, you can register, but must notify FDA when you start producing. After 6 months, if you haven't notified FDA that you have started an activity requiring registration the registration form is archived and you are not registered. |
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