Failure to Register Notice
Notice: Failure to update FDA annual registration Form 3356
FDA has noticed an increase in "Failure to Register," where reporting officials did not update their annual registration. This is a reminder as required in 21 CFR 1271.21, that Annual update of your registration is required every year in December.
- Changes to your HCT/P listing is required within 6 months of the change.
- If the ownership or location of the establishment changes, an amendment to the establishment registration must be submitted within 5 days of the change.
- If the facility is no longer in operation, check box 2 (d).
- Remember to always sign and date your Form 3356 in box # 9. Unsigned forms will not be processed.
Questions can be addressed to Rosemarie Wiseman 301-827-6176 or email tissuereg@fda.hhs.gov
Additional information concerning tissue establishment registration and product listing information can be found at http://www.fda.gov/cber/tissue/tisreg.htm