Documentation required for launch of a non-sterile exempt class 1 medical device

A

Achemd

#1
Can anyone advise me what documentation is required from a regulatory point of view to launch a non-sterile exempt class 1 medical device.
:thanx: AchemD
 
Elsmar Forum Sponsor
#4
Can anyone advise me what documentation is required from a regulatory point of view to launch a non-sterile exempt class 1 medical device.
:thanx: AchemD
Class I devices need to comply with General Controls and thus the procedures would include the list of procedures required as per 21 CFR Part 820 and ISO 13485.

You can search this forum to get a list of procedures required for 21 CFR Part 820 and ISO 13485.
 
D

debiamp

#5
To commercialize a class 1 exempt device you do not need anything from FDA but you really should document to file (internally) the justification you are using that identifies the device as class 1 and exempt. You should copy the FDA product code and classification regulation page that supports your decision. Remember not all class 1 devices are exempt from QSR requirments.
 
D

debiamp

#6
If you are not sure that you are correct in the classification you could send a 513g request to FDA.
 
A

Achemd

#7
Thanks all, it is a definate class 1 so will register the device. Do we need to do a Charter, DID/DOS and Design History etc ? Seems overkill for class 1.
 
D

debiamp

#8
I am not familiar with a Charter, DID/DOS. You do have to list the device and register your establishment. As far as design history, many class 1 devices are exempt from this. You have to check and see if yours is not.
Per 820.30(a) - The following class I devices are subject to design controls:
(i) Devices automated with computer software; and
(ii) The devices listed in the chart below.
Section Device
868.6810 Catheter, Tracheobronchial Suction
878.4460 Glove, Surgeon's
880.6760 Restraint, Protective
892.5650 System, Applicator, Radionuclide, Manual
892.5740 Source, Radionuclide Teletherapy
 
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