FDA: 522 Reform Could Lead to More Discussions, Longer Response Time

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The FDA will consider adding a mandatory pre-522 discussion period before issuing postmarket surveillance orders, officials at an FDA public workshop of the process said Wednesday. The early meeting could spell relief for devicemakers, which have complained the 522 process is too rushed. Currently, companies have only 30 days to respond with a study design after the agency calls for a postmarket study — not nearly enough time to complete the 522 process, panelists discussing collaborative challenges and opportunities of 522s agreed.
Devices & Diagnostics Letter

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