ISO 13485 certified as precursor to regulatory compliance to 21 CRF Part 820?

catss

Registered
#1
Hi
sorry if this has question has already been asked, but I can't seem to find an answer.

Is it necessary to be certified to 13485 before ensuring conformity to 21 CFR Part 820, for sale of medical software in the USA.

We are a small biotech spinout, and the plan is to obtain FDA clearance first before launching in other countries.
We are not ISO 13485 yet.

Any advice or tips really appreciated!
Thanks very much!
 
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nvquality

Starting to get Involved
#2
Although there is talk of FDA recognizing ISO 13485 in the future, especially in light of the MDSAP, it doesn't yet. So you don't need ISO certification although it's a good idea to look at 13485 already as you're developing procedures.

Also the FDA has a handy database that will let you check if they recognize a particular standard. I can't post the link but you can search for "FDA consensus standard database".
 

somashekar

Staff member
Super Moderator
#3
Hi
sorry if this has question has already been asked, but I can't seem to find an answer.

Is it necessary to be certified to 13485 before ensuring conformity to 21 CFR Part 820, for sale of medical software in the USA.

We are a small biotech spinout, and the plan is to obtain FDA clearance first before launching in other countries.
We are not ISO 13485 yet.

Any advice or tips really appreciated!
Thanks very much!
If you can align your QMS with the 21CFR820, you do not need to be certified to the 13485.
Rather I would say that your good hold on the 21CFR820 will help you to get the 13485, if you so require at a later date.
Good Luck...
 

catss

Registered
#4
Thank you Nvquality and Thank you Somashekar - both clear and useful advice.
Can I ask a follow-up question - will the FDA perform an audit of the QMS before clearing the software medical device for sale in the USA, as submitted via the PMA route?
Thank you very much again.
 

Al Rosen

Staff member
Super Moderator
#5
Thank you Nvquality and Thank you Somashekar - both clear and useful advice.
Can I ask a follow-up question - will the FDA perform an audit of the QMS before clearing the software medical device for sale in the USA, as submitted via the PMA route?
Thank you very much again.
I believe they will audit after you make a submission.
 

somashekar

Staff member
Super Moderator
#7
Thank you Nvquality and Thank you Somashekar - both clear and useful advice.
Can I ask a follow-up question - will the FDA perform an audit of the QMS before clearing the software medical device for sale in the USA, as submitted via the PMA route?
Thank you very much again.
A FDA inspection may or may not happen. Its not like this follows that. You need to be prepared at all times. If they decide to inspect you, FDA will approach you perhaps on a call... Good Luck
 
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