change in medical device classication?, page-4

im speechless, they give themselves 210 days leeway to complete this work?

what exactly does a bunch of pen pushers in government hope to determine from manufacturing data?

how did these guys go looking over the manufacturing data of Poly Implant Prothese breast implants?

im sure the switch to industrial silicone probably happened after approval, so wouldnt a regime of continual testing be more appropriate?

if any of them understood the data they would have a real job in the real world