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Re: New Establishment Registration and Device Listing Rule
I spoke with FDA today and learned two bits of information:
1. No guidance will be forthcoming before October 1, when the program commences.
(As a side point, I think a post earlier in the thread says that this is due October 1...not so, October 1 is the earliest you can Register and List for FDA year 2013, with December 31 being the last day for such activity before penalties and regulatory actions could apply.)
2. Outside-US Contract Manufacturers always have been required to Register and List. Under the new system, outside-US sterilization and packaging subcontractors also will be required to Register and List.
I spoke with FDA today and learned two bits of information:
1. No guidance will be forthcoming before October 1, when the program commences.
(As a side point, I think a post earlier in the thread says that this is due October 1...not so, October 1 is the earliest you can Register and List for FDA year 2013, with December 31 being the last day for such activity before penalties and regulatory actions could apply.)
2. Outside-US Contract Manufacturers always have been required to Register and List. Under the new system, outside-US sterilization and packaging subcontractors also will be required to Register and List.