FDA's Medical Device Quality Systems Manual Withdrawn (2013)

Mandy

Involved In Discussions
#1
I was really upset to find on the FDA website that their very comprehensive and useful guide the "Medical Device Quality Systems Manual" has been withdrawn.:(
Does anyone know why this is and if they are planning to put it back up? :confused:
Thanks,
Mandy
 
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H

HPLC_Help

#2
Re: FDA's Medical Device Quality Systems Manual withdrawn

Hi, Gazielmd -

My regulatory consultant says it likely has some outdated information somewhere, so that's why it was pulled.

But it was such a useful document! I'm glad I printed a copy a while back. I do wish they'd give some information about pulling the document, instead of just saying "withdrawn" ...
 

Ajit Basrur

Staff member
Admin
#4
Re: FDA's Medical Device Quality Systems Manual withdrawn

Yes, its withdrawn - Link was: http://www.fda.gov/medicaldevices/deviceregulationandguidance/postmarketrequirements/qualitysystemsregulations/medicaldevicequalitysystemsmanual/default.htm
 
Last edited by a moderator:

Mandy

Involved In Discussions
#5
Re: FDA's Medical Device Quality Systems Manual withdrawn

Thanks so much for the attachment Avraham - that is exactly what I need. Most appreciated.
Hope you are well.
Warm regards.
 
O

Oscar Wang

#7
Re: FDA's Medical Device Quality Systems Manual withdrawn

thanks for this sharing. it is very helpful.
 
L

lfrost

#8
Re: FDA's Medical Device Quality Systems Manual withdrawn

I?m looking for the Small Entity Compliance Guide, about 20 pages as I remember it. Not the 468 page Manual. Does anyone have a copy of that guide?

I used to find it here in html-format:
DEAD LINK REMOVED.
Thanks
DavidHefors,

The document that you are requesting has been withdrawn as it states in the link you provided. It is posted in post #3 as a pdf document.
 
Last edited by a moderator:
S

seanlaw

#9
Re: FDA's Medical Device Quality Systems Manual withdrawn

Thank you to all whom has posted,

This is what I need to comprehensively understand the FDA standards with ISO13485, as we recently have a new customer inquiry.

I just browse thru' and I guess why is withdrawn is because this manual has the solutions to all your "how to comply", to medical compliance and this way it will never make $ for FDA and it's consultants.

Thanks again.
 

Ronen E

Problem Solver
Staff member
Moderator
#10
Re: FDA's Medical Device Quality Systems Manual withdrawn

This is what I need to comprehensively understand the FDA standards with ISO13485, as we recently have a new customer inquiry.
Hi,

Not sure what you mean by "comprehensively understand the FDA standards with ISO13485", but if you describe the customer's inquiry we might be able to help.

Cheers,
Ronen.
 
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