ARTICLE SUMMARY:
FDA refused to take premarket inspections off the table for devices seeking de novo authorization, despite arguments from industry that FDA doesn’t have authority to perform the audits and that they remove the efficiency advantages of the de novo process. FDA issued its final rule on the de novo classification process October 4.
Pre-authorization facility inspections will not be routine for devices pursuing the de novo premarket pathway, but FDA will pursue them when necessary to ensure data integrity and to assesses the safety and effectiveness impact of manufacturing processes. That was FDA’s message in its new regulation on the “Medical Device De Novo Classification Process” finalized October 4.
