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On further thought, I realized the best I could do by today was a preliminary draft of the De novo biocompatibility data.  I won't be around to update it, nor to delete it, and I decided I didn't want to leave a preliminary draft posted here in perpetuity, so I decided against posting it here after all ...

This could be wishful thinking on my part, but... To me CDRH's behavior with regard to ISO 13485 has always had something of a "kicking the can down the road" feel to it. I was thinking maybe aiming to postpone it until there was a change in Administration. Or the political winds otherwise changed, ...

NEW PLAN FOR 2021: My plan for this past year was to summarize the biocompatibility data, update some of the earlier data on De novo timeframes, do a slice and dice on a journal article and an industry report, and then roll out my Regulatory Watchcat website.   I expect to get to the rest of ...

UPDATED 12/2020: Everyone has their "This was the year I was going to…" stories.  This one is mine. I had to chuckle when I re-read the first sentence of my post last February.  Apparently I overlooked a fourth option, oops. The last sentence made me laugh darkly, as I ended up mostly reacting ...

Interesting question.  I'm not sure the data are available to answer it.  Also not sure enough drugs have had testing abridged to generate much data to answer the question. My own perspective is influenced heavily by the high failure rate of medical startups, of which "abridging" seems to be a leading ...