A PCCP allows manufacturers to include a detailed plan for future device changes within a 510(k), PMA, or De Novo submission. Once approved by the FDA, the PCCP allows manufacturers to implement ...
FDA encourages manufacturers to consider whether a Predetermined Change Control Plan (PCCP) might also be appropriate in the submission and references the Agency’s final guidance, issued last ...
The new guidance follows final guidance the FDA issued last month on pre-determined change control plans (PCCP), a framework for changes to devices after they are on the market. Currently ...
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