ADT: 'Fever' Cameras Are Medical Devices

By John Honovich, Published Jun 15, 2020, 10:11am EDT (Info+)

While many manufacturers are avoiding admitting their 'fever' cameras are medical devices, ADT has taken a strong and clear position.

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ADT has taken one of the most conservative and well-researched positions that IPVM has seen. Inside this note, we examine ADT's position, their explanation, and how it could hurt their sales relative to competitors.

For related coverage, see Fever Cameras Are Medical Devices, Per The FDA, Dahua, Feevr, Hikvision, InVid Contrary Claims Are False and ZKTeco SpeedFace+ Are Medical Devices, Per FDA Definition, Contrary Claims Are False.

Medical *******

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** * **** **** *******, *** Commercial's ****** ******* *******,***** *****, *********:

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***** ** *********** *** *******, ******** **** *** ***'* ********'* declaration ** **** ******:

"Not **** * **** *** ***"

***'* ******* ********** ***** *** ******* concluded **** ** * '**** *** all' ********* ******* *************, ******:

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Abuse *** *****************

**********, ***'* ******* ********** ***** *** misrepresentation *********:

** ** *** ****** **** **** the ******** ****, *** *** **** pick ***** **** ** **** *** enforcementperhaps **** **** ********** *********** *** ****** ** ***** *** ***************** we're likely to see with medical devices and other pharmaceuticals during this pandemic period. [emphasis added]

Risk ********* *** ********** ******

*** ****** ** *****, *** ********, could ** ********* ** ********** ******:

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Not ***** ********* ******

*** ********** ********* **** **** *** not ******** ***** *********, ********** ** describe ***** ** '******** **** ***********' detection *********. ** ** ********* **** '***** ********', **** **** '***', *** ************ *** ******** ******** is ** **** ***** ******* **** temperature *********.

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Correct ********

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Bad *** *** ******** ***** ****

** *** ***** ****, **** ** many ** ***'* *********** ******* ******** that ***** *** ******* *******, *** stands ** **** ***** **** ******** as ****** *** ***** **** ********* products **** **** ********** *********** ******. However, ** **** ******* *** *****, most ** ***** ******* **** *********** performance ********.

***** *** *** **** ** *** short ****, ** *** *** ** customers ********** ****** ***** ****** ******* these *******, *** *** ** ****** in *** **** ***. *******, ******* or *** **** ***** ****** **** come ** *** ****** ******* ** be ****.

Comments (12)

Any insight on when FDA will end their CV-19 suspension of 510(k)?

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Skip, from our April 2020 reporting when this was first announced:

The FDA emphasized that this guidance is temporary:

"This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by HHS"

There is no indication of when HHS will declare COVID-19 to no longer be a public health emergency; yesterday, an-all time high of over 2,400 Americans died from the virus and over 500,000 have tested positive so far.

The last US public health emergency was Swine Flu, which lasted well over a year - it was declared in April 2009 and ended in June 2010. Given COVID-19's greater impact, it will likely last at least as long, if not significantly longer.

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Another factor is that some manufacturers have submitted their devices for FDA approval, but must wait out the usually very long processing time.

If the devices pass muster, there is not likely to be a backlash against the units already installed, unless the FDA forces the manufacturer to remove the installed devices and replace them with the same device with the sticker attached.

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unless the FDA forces the manufacturer to remove the installed devices and replace them with the same device with the sticker attached.

We have not seen anyone even suggest that, have you? Also, to be clear, there is no physical 'sticker' involved.

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I think any manufacturer that has submitted for the 510K or other cert process is showing they are committed to ensuring their products will be compliant long term. They're not likely to be the ones hit with backlash, it's going to be the others who aren't even pursuing the certification and making claims they aren't a medical device per FDA that are going to come up short.

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The question that I have regarding FDA approval is in regards to the actual device being approved and what substantiates the certification over time.

When I look at for instance the FDA approval for the Flir camera

It's dated 2004 and it covers models, maybe I am not seeing the later updates in the database. But their Certification shows that it covers:

Proprietary or Trade Name: Series A, E, S, and P - IR cameras

Does this mean that flir cameras released in 2020 as a model "A"400 or "A"700 are grandfathered into the same cert or is there any requirement to resubmit new hardware as firmware and hardware becomes significantly updated or different?

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Hi Evan, good question. Correct, the FLIR devices got FDA 510(k) clearance back in 2004 for those series and hasn't updated since:IPVM ImageAs to your question, the FDA says a new submission is only required if there are significant modifications or a "different intended use":

A new 510(k) submission is required for changes or modifications to an existing device, where the modifications could significantly affect the safety or effectiveness of the device or the device is to be marketed for a new or different intended use [emphasis added]

The FDA further explains:

Major modifications to the device likely require premarket review by the FDA, while minor changes likely do not.

A premarket notification (510(k) is required when a legally marketed device subject to 510(k) requirements is significantly changed or modified in design, components, method of manufacture, or intended use.

Given that FLIR has not received new 510(k)s, it's likely they would say these devices have not been "significantly changed" enough to warrant a new 510(k).

As the FDA explains, there is no amendment/supplement/etc to an existing 510(k). If the changes are substantial enough, then an entirely new 510(k) "must be submitted":

There are no provisions for a 510(k) amendment or supplement to the existing 510(k).If it is determined the modification is not covered by the current 510(k) a new 510(k) must be submitted.

Agree: 2
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I wonder how many other cameras from 2004 are still relevant today based on all the technology changes and enhancements.

Also, I'm wondering if Flir could possibly be using the same silicon, components and firmware from 2004 to produce this most latest version which is substantially the same.

Let's say it's the same camera and nothing significant has changed, are we also to believe that the camera is no better than it was say 16 or 17 years ago?

Just a random thought as I read IPVM with a beer after a long day.

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I can’t imagine Bill at Seek or Shawn Dirksen knowing anything about product changes since 2004. Or, any reason Bill would “poke a stick” at FLIR.

Agree: 2
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As an ADT competitor I truly and honestly applaud their thoroughness.

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I never in a million years thought I would be thinking this, let alone typing it, but good for ADT!

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I think as much or more a concern than legal action from the FDA or customer suing the integrator will be from individuals (or a group) denied access via such a system who suffer lost wages or otherwise suffer harm.

Most companies are deploying these types of screening solutions to reduce legal risk due to an infected person entering their facility and spreading that infection to others, however that's offset by the risk of the lawsuit from those denied access.

That's why from a legal standpoint, using an FDA approved device, in the way the FDA and International standards state they should be used will be key in being able to defend against such lawsuits, both for the customer and the integrator.

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