Use of FDA Cleared logo on packaging

#1
I have a customer who just added an "FDA Cleared" logo to their product box. we are the mfg. of said product which is classified as follows:

Description: Exerciser, non-measuring
Product code: ION
Device Class: 1
Regulation No: 890.5370

Submission type 510(K) Exempt
GMP Exempt Yes, except for section 820.180 General requirements concerning records and 820.198 regarding complaints)

My question is whether or not it is ok for them to put this logo on the product since it is exempt and doesn't require fda clearance? I haven't had a lot of experience with FDA regulations other than part 820 of CFR 21 and couldn't find a clear answer on anything I read on the FDA website. Any help is greatly appreciated!
 
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ScottK

Not out of the crisis
Staff member
Super Moderator
#2
Is It Really 'FDA Approved?'

FDA uses a risk-based, tiered approach for regulating medical devices.
FDA classifies devices according to risk. The highest-risk devices (Class III), such as mechanical heart valves and implantable infusion pumps, generally require FDA approval of a premarket approval application before marketing. To receive FDA approval for these devices, manufacturers must demonstrate with sufficient, valid scientific evidence that there is a reasonable assurance that the devices are safe and effective for their intended uses.
Generally, FDA “clears” moderate-risk medical devices (Class II) (for example dialysis equipment and many types of catheters) for marketing once it has been demonstrated that the device is substantially equivalent to a legally marketed predicate device that does not require premarket approval.
Devices that present a low risk of harm to the user (Class I) (for example non-powered breast pumps, elastic bandages, tongue depressors, and exam gloves) are subject to general controls only, and most are exempt from premarket notification requirements.

Sounds like BS marketing to me for a Class I 510k exempt as the FDA would barely even look at it, never mind "clear" it. All they've done is register their establishment and product
 
#3
Marketing is pretty much my thought as well.

as the mfg. though, i didn't want it to seem like we were stating it's FDA cleared as we are final packing and shipping it and was concerned we would be violating some type of guideline. We mfg other class I and II devices however they are not exempt and have all the appropriate controls in place. this particular customer just changes stuff.
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#4
Marketing is pretty much my thought as well.

as the mfg. though, i didn't want it to seem like we were stating it's FDA cleared as we are final packing and shipping it and was concerned we would be violating some type of guideline. We mfg other class I and II devices however they are not exempt and have all the appropriate controls in place. this particular customer just changes stuff.
Whose name is on the product? Yours or theirs?
If their name is on the product, document that you advised them that this marking may not be appropriate and you wash your hands of it if they insist on keeping it. Then the FDA takes it up with them if they object.
 
#7
I saw that and read through it. They aren't putting the fda logo per that policy on the box.

they are putting FDA cleared per attached pic. it's still a class I exempt device though so according to what i read, it wouldn't be "fda cleared" & being the mfg that is shipping these to the distributors, we aren't comfortable using these boxes.

I sent them a letter asking what their intent is with adding this to the product & stated that it wouldn't be fda cleared. waiting for their response at this point.
 

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JeantheBigone

Quite Involved in Discussions
#8
If it's Class I exempt, then it isn't cleared, it's exempt. Clearance means the device successfully went through the 510(k) process. Putting "FDA cleared" on the package is incorrect. The product is "listed" with FDA but even so, I would advise against putting that on the packaging. The fact that it is listed only means that they are in compliance with general controls. It's likely that FDA would regard this type of wording as an attempt to imply that FDA somehow endorses the product. FDA doesn't like it when manufacturers do that, although it is also unlikely that the company would get a warning letter over it unless there are other violations.
 
#9
thanks so much. that is exactly what i got out of everything i read up on, no fda cleared for exempt product. just wanted to be sure what i was getting out of google/fda site was correct.
 
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