On: How Boeing, FAA certified the suspect 737 MAX flig...

[refurb]

That might be true for the FAA, but it's not true for the FDA. They will ask companies for original data and then replicate analyses.

[jfk13 → refurb]

But do they replicate how that "original data" was generated or gathered?

[refurb → jfk13]

No, because the FDA doesn’t have the resources to actually redo a trial.

What they do is ask the manufacturer to lay out how they run the trial before they start.

If you bring data back to the FDA that doesn’t match up (fewer patients, different measurements) you can expect a rejection.

[Gibbon1 → jfk13]

Friend of mine was working for a medical device group. One of the managers removed some negative patient data from the reports they filed with the FDA. The FDA when they figured it out responded with an outright rejection that was final.