The post below I wrote about three years ago and at that time did not mention that the caller was inquiring about my interest and ability to participate in the FDA panel looking at digital pathology back in the Fall of 2009. That panel of course was put together which I have mentioned on prior occasion (see The FDA States, WSI Systems Are Not Class I Exempt (10/23/2009)).
Nothing of significance happened until the FDA was invited to speak at Pathology Visions 2011 which I made a few notes about on a related story earlier this year (see Regulators regulating digital scanners).
Since that discussion there appears to be a standoff between manufacturers and the FDA.
There does not appear to be any movement by either side short of the FDA opening up some positions for digital pathology specialists (more on this next week).
Manufacturers appear to be either (1) looking for opportunities overseas to sell products and services, (2) looking at leveraging cloud computing to facilitate consultations (from overseas or within the USA) or (3) waiting for each other to submit for the first intended use studies while the FDA waits for submissions after stating publicly that whole slide imaging devices would not be considered Class I devices (exempt) and cannot be treated as a laboratory developed test (LDT). In the meantime, "Approved for Primary H&E Diagnosis" is not available in the US of A.
Based on the post below given my first interaction with FDA on this matter I cannot say that any of this is terribly surprising. Neither side, particularly the FDA seems that intersted in putting the necessary resources behind this matter on behalf of the imaging or the laboratory community to facilitate necessary validation and clearances. I can't blame the manufacturers here either. It is going to take significant time and resources in a difficult business climate with slow adoption and use for what will have to be clearly defined intended uses and therefore limited use whether by tissue type, specimen source and/or defined or excluded histochemical/immunohistochemical/fluorescence stains.
When will the standoff end?
A couple of weeks ago - 6:30 AM phone call
This interaction actually happened and reminded me of this New Yorker cartoon about New York and “everything else”.
Caller: Dr. Kaplan, this is Mr. So and So from the [name of a government agency]. I am calling to inquire about your interest in reviewing grant submissions. I hope you are not driving.
Me: No. I was sleeping.
Caller: Good. I hope I am not disturbing you but I need to know if you can come to [a city in the US] in January when we convene the review panel.
Me: What dates In January?
Caller: We do not know yet but I need to know right now if you can come.
Me: I suppose it depends a little bit on what I will be reviewing, if I have anything to offer and if I don't have a prior conflict.
Caller: OK. I will just need to collect some basic information such as your social security number, home address and place of employment.
Me: Mayo Clinic.
Caller: Where is Mayo Clinic?
Me: Rochester, Minnesota.
Caller: Where is Minnesota?
At this point I start asking some questions about who this individual is, his civilian pay grade, where his office is located, how he knew where to contact me and check the caller ID for area code.
Me: Have you seen 'Taking Chance'?
Me: 'Grumpy Old Men'?
Caller: No. What time zone are you in?
Caller: Oh, Minnesota is in the middle.