510k exemption process - Do you still need to submit technical dossier?

#1
I have a doubt about the 510K exemption process.

If a device is 510k-exempted, do you still need to submit technical dossier (e.g. information on safety of the device and compliance to 10993, 60601 etc) to FDA?

Or the only things to do should be to perform registration and listing and start to sell the device?
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
The General Controls apply to all device types except where explicitly exempted.

General Controls for Medical Devices

Some Special Controls may apply, additionally, to some class II device types.

The first and most important step is to correctly classify your device in terms of the FDA 3-letter code. Normally this is done by identifying an equivalent device already legally in commercial distribution in the USA. Once you identify the device, look up its 3-letter code and go from there to see what Controls apply and whether the device type is exempt from premarket notification (510k), GMP (QMS), Design Controls etc.

Use this page to find codes for devices already on the market: Establishment Registration & Device Listing
Use this page to find applicable exemptions and Special Controls: Product Classification

Normally where a device is 510k exempt there's no need to submit technical documentation similar to what you listed.
 
#3
Thanks for your reply. So in case I have already identified the product code, I have QMS in place and general and special controls documented.
The only things I need to do from the practical point of view to start to sell in US is 1) Registration and Listing 2) a petition to FDA stating the reason why we believe the device is exempted from 510k application.

Is that correct?
 

Ronen E

Problem Solver
Staff member
Moderator
#4
No. If the product code page states that the code is 510k exempt then no petition is necessary. But you do need some documentation on file to justify that this is indeed the right code.

Registration and Listing are part of the General Controls.

What's your code?
 
#5
My code is GZM. Is a class II 510K exempt.

What I do not understand is these two key points:

a) From documentation point of view, apart being compliant to CFR 820 (QMS, design documentation etc), is there any specific documents needed to sustain the 510k exemption?
b) From the FDA sides, once I am sure that General Controls and applicable Special Controls have been addresses, I can start to sell the device in US without any notification to the agency?
 
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