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NTI Letters Threaten Industry’s Input on Submission Requirements

June 20, 2011
CDRH is touting notice-to-industry (NTI) letters as a way to quickly communicate new submission expectations, but devicemakers are worried about regulatory changes without opportunities for comment. In some instances, NTI letters would equate to level one guidance, meaning a change is effective immediately, the FDA said Wednesday in a standard operating procedure (SOP) document on the letters. Public comment prior to issuance may not be “feasible or appropriate due, for instance, to the potential public health impact,” it adds.  
Devices & Diagnostics Letter