I work for a med device company that aids in diabetes maintenance. Nothing serious of the device or a defect that could lead to death. The amount of scrutiny the FDA puts in a submission, asking for clarifications and further proof multiple times throughout the review process leading up to approval. If it’s considered a brand new device ( not an improvement on a currently approved device) you can expect an audit at the clinical sites and sponsor level in which they tear apart any mistake you made in terms of documentation. Heck, you could send correspondence to the site a few days outside your SOP says it should be sent out and you can get your submission put on hold and kick off a deeper review of your documents. And they were bamboozled by Pfizer for a ‘vaccine’ with groundbreaking technology of mRNA and its not for a group of people, like say, diabetes. It’s intended for the global population. Fuck that.
I work for a med device company that aids in diabetes maintenance. Nothing serious of the device or a defect that could lead to death. The amount of scrutiny the FDA puts in a submission, asking for clarifications and further proof multiple times throughout the review process leading up to approval. If it’s considered a brand new device ( not an improvement on a currently approved device) you can expect an audit at the clinical sites and sponsor level in which they tear apart any mistake you made in terms of documentation. Heck, you could send correspondence to the site a few days outside your SOP says it should be sent out and you can get your submission put on hold and kick off a deeper review of your documents. And they were bamboozled by Pfizer for a ‘vaccine’ with groundbreaking technology of mRNA and its not for a group of people, like say, diabetes. It’s intended for the global population. Fuck that.