ADT: 'Fever' Cameras Are Medical Devices
While many manufacturers are avoiding admitting their 'fever' cameras are medical devices, ADT has taken a strong and clear position.
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 *******
** * **** **** *******, *** Commercial's ****** ******* *******,***** *****, *********:
** ** *** *** ********* ******** on **** **** ******** ***** **, we ****'* **** ** ***** *** we ****'* **** ** *** ** wrong. ** ** ********* *** ******* we *** **** *** **** *** the ********, ** **** **** *** own ******** ******* ****** **********, *** our ********** ** **** ***** **no **** ******** in the face of the FDA. The cameras used for the purposes we intend for our customers to use them, to measure relative skin surface temperature for the safety of your employees and occupants, to ******* **** **** *** *** ******* *******. So we concluded and we are continuously convinced that these ******* *** *** ********* *** ***** *** *******, even when used in a non medical environment that's very important. [emphasis added]
***** ** *********** *** *******, ******** **** *** ***'* ********'* declaration ** **** ******:
"Not **** * **** *** ***"
***'* ******* ********** ***** *** ******* concluded **** ** * '**** *** all' ********* ******* *************, ******:
*** *** ** ******** **** ********* relaxation ***** *** *** **** * keep ******* ***** **** *** *** has ******* *** ************ *** ***** devices. ****, *** ** *******. ** April, ** ******** ** *** ******** and ********* *** ********* **** ********** is ***** ** ** ** *** back ** **** ******, *** *** told ** *** **** **** **** to ***** ******* *********** ** ********* and **********, ************ ************ *** ***** devices. **, *****, **'* **** **** respect ** ******* ********* *** ************ requirements. ** ***** ** ** ******** for **** *****, *******, **** ****, you **** ** ******* **** *** paperwork, ***********. ***have ** ********* **** * ******* **** ** ******** *** ******** ************. ** **'* *** **** * **** *** ***. Unfortunately, many ******* *** ****** ******* ************* **** ************** **** *********** to mean that any product can be sold, you've no doubt seen the flood out there in the marketplace. [emphasis added]
Abuse *** *****************
**********, ***'* ******* ********** ***** *** misrepresentation *********:
** ** *** ****** **** **** the ******** ****, *** *** **** pick ***** **** ** **** *** enforcementperhaps **** **** ********** *********** *** ****** ** ***** *** ***************** we're likely to see with medical devices and other pharmaceuticals during this pandemic period. [emphasis added]
Risk ********* *** ********** ******
*** ****** ** *****, *** ********, could ** ********* ** ********** ******:
*** ******* ** **** ** **** we **** ******** **** *** ***** be ******** ******** **** ****** ********** results ** ******** **** *** *** customers *** **** *** **** **risk ** ********* ******* ******* *********, or being the subject of negligence ****** in the even these products are not accurate and don't work. [emphasis added]
Not ***** ********* ******
*** ********** ********* **** **** *** not ******** ***** *********, ********** ** describe ***** ** '******** **** ***********' detection *********. ** ** ********* **** '***** ********', **** **** '***', *** ************ *** ******** ******** is ** **** ***** ******* **** temperature *********.
** ******, ** *** **** ****, elevated **** *********** ** ***** **** as * ***** *** ********* ******** body *********** ***** ** * ********* sign *** ***** ***** ** ****** a ********* ********* ** ***********, ***** is *** *** ****** *** ***** devices ** ** ***** ****** * coronavirus ********.
Correct ********
**** ****** **** *** ** **** point, ** ** ************* ** ****** ** *** ******* devices ********, ***** ******* *** ******* ******** for * ******* ******* *** ******* that **** *** *** ******* ******* runs ******** ** *** ***'* ********** and ******* **** ************* ** ***** risk *** *** ****** ** * false ***** ** ****** *** ********.
Bad *** *** ******** ***** ****
** *** ***** ****, **** ** many ** ***'* *********** ******* ******** that ***** *** ******* *******, *** stands ** **** ***** **** ******** as ****** *** ***** **** ********* products **** **** ********** *********** ******. However, ** **** ******* *** *****, most ** ***** ******* **** *********** performance ********.
***** *** *** **** ** *** short ****, ** *** *** ** customers ********** ****** ***** ****** ******* these *******, *** *** ** ****** in *** **** ***. *******, ******* or *** **** ***** ****** **** come ** *** ****** ******* ** be ****.
****,**** *** ***** **** ************* **** *** ***** *********:
*** *** ********** **** **** ******** is *********:
"**** ****** ** ******** ** ****** in ****** **** *** *** ******** of *** ****** ****** ********* ******* to *****-** ******** ** ***"
***** ** ** ********** ** **** HHS **** ******* *****-** ** ** longer ** * ****** ****** *********; yesterday,**-*** **** ****** **** *,*** ********* **** **** the ***** ******* ***,******* ****** ******** ** ***.
*** **** ** ****** ****** ********* was ***** ***, ***** ****** **** over * **** - ***** ******** ** ***** ************ ** **** ****. ***** *****-**'* ******* ******, ** will ****** **** ** ***** ** long, ** *** ************* ******.
******* ****** ** **** **** ************* have ********* ***** ******* *** *** approval, *** **** **** *** *** usually **** **** ********** ****.
** *** ******* **** ******, ***** is *** ****** ** ** * backlash ******* *** ***** ******* *********, unless *** *** ****** *** ************ to ****** *** ********* ******* *** replace **** **** *** **** ****** with *** ******* ********.
****** *** *** ****** *** ************ to ****** *** ********* ******* *** replace **** **** *** **** ****** with *** ******* ********.
** **** *** **** ****** **** suggest ****, **** ***? ****, ** be *****, ***** ** ** ******** 'sticker' ********.
* ***** *** ************ **** *** submitted *** *** **** ** ***** cert ******* ** ******* **** *** committed ** ******** ***** ******** **** be ********* **** ****. ****'** *** likely ** ** *** **** *** with ********, **'* ***** ** ** the ****** *** ****'* **** ******** the ************* *** ****** ****** **** aren't * ******* ****** *** *** that *** ***** ** **** ** short.
*** ******** **** * **** ********* FDA ******** ** ** ******* ** the ****** ****** ***** ******** *** what ************* *** ************* **** ****.
**** * **** ** *** ******** the *** ******** *** *** **** camera
**'* ***** **** *** ** ****** models, ***** * ** *** ****** the ***** ******* ** *** ********. But ***** ************* ***** **** ** covers:
*********** ** ***** ****: ****** *, E, *, *** * - ** cameras
**** **** **** **** **** ******* released ** **** ** * ***** "A"400 ** "*"*** *** ************* **** the **** **** ** ** ***** any *********** ** ******** *** ******** as ******** *** ******** ******* ************* updated ** *********?
** ****, **** ********. *******, *** FLIR ******* *** *** ***(*) ************* ** ******* ***** ****** *** ****'* ******* since:
* *** ***(*) ********** ** ******** for ******* ** ************* ** ** existing ******,where *** ************* ***** ************* ****** *** ****** ** ************* ** *** ****** ** *** ****** ** ** ** ******** *** * *** ** ********* ******** *** [emphasis added]
***** ************* ** *** ****** ****** require ********* ****** ** *** ***, while ***** ******* ****** ** ***.
* ********* ************ (***(*) ** ******** when * ******* ******** ****** ******* to ***(*) ************ ** ************* ******* or ******** ** ******, **********, ****** of ***********, ** ******** ***.
***** **** **** *** *** ******** new ***(*)*, **'* ****** **** ***** say ***** ******* **** *** **** "significantly *******" ****** ** ******* * new ***(*).
** *** ***********, ***** ** ** *********/**********/*** ** an ******** ***(*). ** *** ******* are *********** ******, **** ** ******** new ***(*) "**** ** *********":
***** *** ** ********** *** * 510(k) ********* ** ********** ** *** existing ***(*).** ** ** ********** *** modification ** *** ******* ** *** current ***(*) * *** ***(*) **** be *********.
* ****** *** **** ***** ******* from **** *** ***** ******** ***** based ** *** *** ********** ******* and ************.
****, *'* ********* ** **** ***** possibly ** ***** *** **** *******, components *** ******** **** **** ** produce **** **** ****** ******* ***** is ************* *** ****.
***'* *** **'* *** **** ****** and ******* *********** *** *******, *** we **** ** ******* **** *** camera ** ** ****** **** ** was *** ** ** ** ***** ago?
**** * ****** ******* ** * read **** **** * **** ***** a **** ***.
* ***’* ******* **** ** **** or ***** ******* ******* ******** ***** product ******* ***** ****. **, *** reason **** ***** “**** * *****” at ****.
** ** *** ********** * ***** and ******** ******* ***** ************.
* ***** ** * ******* ***** thought * ***** ** ******** ****, let ***** ****** **, *** **** for ***!
* ***** ** **** ** **** a ******* **** ***** ****** **** the *** ** ******** ***** *** integrator **** ** **** *********** (** a *****) ****** ****** *** **** a ****** *** ****** **** ***** or ********* ****** ****.
**** ********* *** ********* ***** ***** of ********* ********* ** ****** ***** risk *** ** ** ******** ****** entering ***** ******** *** ********* **** infection ** ******, ******* ****'* ****** by *** **** ** *** ******* from ***** ****** ******.
****'* *** **** * ***** **********, using ** *** ******** ******, ** the *** *** *** *** ************* standards ***** **** ****** ** **** will ** *** ** ***** **** to ****** ******* **** ********, **** for *** ******** *** *** **********.
*** ******* ** **** *** **** end ***** **-** ********** ** ***(*)?