Importance of Medical Device Accessory Design Controls

K

kingkobra

#1
Hello ,

My questions is about design control .

1)Is it a part of general controls/ Special controls ?

2)If I am making the mobile application as an accessory to the existed medical device then how important this design control is ?

Thanks in advance.
 
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sagai

Quite Involved in Discussions
#2
Re: Importance of Design Controls

Welcome!

Let me share my opinions quickly.

1)Is it a part of general controls/ Special controls ?
The corresponding general control is:
http://www.accessdata.fda.gov/scrip...Part=820&showFR=1&subpartNode=21:8.0.1.1.12.3

and one of the major special control is:
http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm070627.htm

2)If I am making the mobile application as an accessory to the existed medical device then how important this design control is ?
I think accessories also considered as devices from the commercialisation and the corresponding regulatory prospective.
So basically as long as you are the one who commercialises the accessories, at the time you apply for the premarket review, you also commit that you complies with all corresponding CFRs and with the FDC Act of course.

Cheers!
 
T

treesei

#3
Re: Importance of Design Controls

sagai is right about the accessories. An accessory takes the same class as the device. The FDA recently published a guidance for mobile medical apps. Apps as accessories is one of the focus areas.
 
T

Tonyw

#4
Re: Importance of Design Controls

sagai is right about the accessories. An accessory takes the same class as the device. The FDA recently published a guidance for mobile medical apps. Apps as accessories is one of the focus areas.
Hi treesei, I was wondering if you can point me to the guidance for mobile medical apps. I'm interested in reading this. Cheers!
 
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