FDA class 2 Device QS Requirements

#1
Hi all,

Looking for thoughts and advice please!!
We are a UK based manufacture of a Class I medical device, currently no ISO 9001 or 13485
Submission for 510k file indicate Class 2 FDA device. We are happy to go along with this as we have all relevant testing data etc.

What I am looking for is the FDA QS requirements, I am gearing up the systems to be 13485 compliant however with the cost (and timelines) there is a reluctance from the board to progress forward with 13485 certification through a notified body.

Are there any requirements from the FDA to have a certified Quality Management System for an FDA Class 2 device?

Look forward to your thoughts on this
 
Elsmar Forum Sponsor
#2
You need to follow General Controls, which means you need to follow good manufacturing practices. This means you must set up your quality system to be compliant to the quality system regulation, 21 CFR 820, here: CFR - Code of Federal Regulations Title 21
21 USC 360j: General provisions respecting control of devices intended for human use

There is no need to have an ISO 13485 certification! If the FDA audits you, they will most likely visit after you have submitted a 510K.

However, if you would like to go for MDSAP, this is where a certification is needed. See here: Medical Device Single Audit Program (MDSAP) and What is MDSAP? The Medical Device Single Audit Program Explained

Hope that helps.
 
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