The one thing that would concern me (as an integrator) is a customer seeing how much margin was built into your product that you could just discount it this significantly. I doubt they are losing money on the camera and are trying to find the right price point to unload these.
I'll be interested to read other comments and opinions.
We have asked the FDA and have not found any way to verify with them whether someone has applied. A company can be listed as an organization in the FDA directory but that does not mean they have applied.
Avigilon responds and confirms not planning to obtain 510(k):
We continue to deliver the H4 ETD Solution under the COVID Pandemic Enforcement Policy for Thermographic Systems and have been careful to follow those guidelines diligently. Unless there is a change to the market demand for such solutions we don't plan to proceed with 510(k) certification.
That's all fine and good while we remain in a state of emergency and the FDA is suspending enforcement. My question is what happens after the state of emergency is lifted? Does the customer need to stop using it or risk enforcement from the FDA or is enforcement only geared toward the manufacturer? What about the integrator who sold it? Even if the FDA won't enforce things with the user, I'm sure a lawyer would latch on to that in a liability or negligence suit against a user deploying an un-certified camera to take temperatures, correct?
Does the customer need to stop using it or risk enforcement from the FDA or is enforcement only geared toward the manufacturer?
What the FDA said exactly was that the FDA "does not intend to object to the distribution and use... where such devices do not create an undue risk." When that stops, they could 'intend' or actually 'object' to such use.
The question is whether people will still be using them after the FDA changes its approach here. The FDA could change this next month or maybe not for years, I don't think anyone knows for sure.
A lot of even the sellers of these systems expect them to be trashed as soon as COVID-19 goes away.