IMO, the FDA's job is to make sure a medical device is safe and effective for the indications that it wants to receive marketing authorization for. If you are working out of a basement or the lab at a billion dollar multi national company the bar is the same.
Another poster assured me yesterday that he had first hand knowledge, it was the opinion of past and present FDA directors that a company must have the means to get a product to market or the FDA would not approve it. I asked for some kind of documentation on this matter and he did not provide it. I mentioned that if it was FDA policy there would have to be a written record, it should even be on the 510k application if it is an approval breaker.
The corner gas station may operate on the thoughts and opinions of its owner. Large companies and Federal Agencies do not operate on the opinions of their directors. If it is a FDA Policy there will be a written record so that all 15,000 employees can refer to it and implement it while doing their job.
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