Center for Drug Evaluation and Research
This guidance provides information regarding the process by which generic drug manufacturers and related industry or their representatives can submit to FDA controlled correspondence requesting information related to generic drug development. This guidance also describes the Agency’s process for providing communications related to such correspondence.
This guidance replaces the September 2015 guidance for industry Controlled Correspondence Related to Generic Drug Development. The September 2015 guidance was issued as part of FDA’s implementation of the Generic Drug User Fee Amendments of 2012 (GDUFA I). This guidance is being issued to incorporate program enhancements related to the review of controlled correspondence to which FDA committed, and industry agreed, as part of the reauthorization of GDUFA (GDUFA II).
Center for Devices and Radiological Health
This guidance provides performance criteria for magnetic resonance (MR) receive-only coils in support of the Safety and Performance Based Pathway. Under this framework, submitters (you) planning to submit a 510(k) using the Safety and Performance Based Pathway for MR receive-only coils will have the option to use the performance criteria proposed in this guidance to support substantial equivalence, rather than a direct comparison of the performance of the subject device to that of a predicate device.
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