I understand that the concept of requiring Design Controls to complete a 510(k) summary seems like common sense, and generally good practice. However, I'm interested in the legality of these companies that we all hear about, that have managed to get a 510(k) cleared without properly documenting their Design Controls.
Say they were to receive clearance, but held off from selling any devices until they have finished off documenting proper Design Controls in their design history file. If the product was then placed in the market after this documentation was completed, and the FDA were to then audit them, would they get pinged for this disparity in the timelines? For example, if the 510(k) was cleared in May and the final Design Controls in the DHF were signed off in July?
Generally curious, but also, my company is really pushing to do exactly that with each project to expedite timelines and it makes me nervous.
Thanks
Say they were to receive clearance, but held off from selling any devices until they have finished off documenting proper Design Controls in their design history file. If the product was then placed in the market after this documentation was completed, and the FDA were to then audit them, would they get pinged for this disparity in the timelines? For example, if the 510(k) was cleared in May and the final Design Controls in the DHF were signed off in July?
Generally curious, but also, my company is really pushing to do exactly that with each project to expedite timelines and it makes me nervous.
Thanks