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NIOSH Approval questions

C

ChrissieO

#1
Thanks for all your help with this in my previous post, which I can't seem to reply to as it is 85 days old:cool: So I will give you a brief synopsis.

FDA and NIOSH Approval - Packaging and Distribution of "Breathing Tubes"

NIOSH approved Respirator manufactures at one plant in UK
Outer packaging and labelling at 2nd plant in UK
Currently have to re-ship back to 1st plant for final approval for shipment to US
Would like to ship direct from plant 2 - what do we need to do?

Is there someone who would be happy for me to contact them ASAP for a little guidence on this as it is becoming a little more pressing time wise and the people I need to speak to from our company all seem to be out of the office this week or have conflicting views from QuantumQuality's post in my original thread - which by the way, I think QQ is along the right lines.

We have applied for our FDA registration which should be through later this week.

If so please PM me your land line number and I will call.

Cx
 
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Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#2
Re: NIOSH Approval

<snip> ....which I can't seem to reply to as it is 85 days old... <snip>
:topic: I am testing a new mod. I have reset it to 180 days and will discuss it in the 'Forum News' forum later today. Technically you can post (Reply) to an old thread if you check the "I am aware that this Discussion Thread is rather old but I still want to Reply" box.
 
D

drquilp

#3
I think you'll need to submit an application for an extension- you can certainly call and ask. The instructions are at www.cdc.gov/niosh/npptl/resources/certpgmspt, and their phone number is 1-412-386-4000. It's a small place- that phone should get you someone that can answer your questions. The more information you have the better. Do you know the Task Number? Do you have the original application for the respirator?
Look at the standard application procedure, and good luck.
 
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