Labelling Requirements for Class 1 Medical Device

[kennethmabou]

Hello,

I wonder if anyone can help? I have a medical device - Class 1, 510K exempt. It is a wall-mounted radiographic cassette holder (to be used in an x-ray room only at the direction of hospital staff, obviously).

I'm not sure of the extent of the information our labelling should contain.

I've searched the FDA relevant guidelines but not sure if all of this is necessary for a Class 1, 510k-exempt device. Can someone please help with the FDA requirements for the label to accompany this sort of device? And does the label have to remain with the Medical Device, or actually fixed to it? Or can we just send, as an Instructions for Use type of thing?

Any help at all would be much appreciated!!

Thank YOU!!

 

[MIREGMGR]

Re: Labelling Requirements for Class 1 Device

A cassette holder should be labeled both as a medical device per 21CFR820 and the related sections, and as a radiolucent device per 21CFR 1010/1020. The labeling should be permanent and on the device unless there is some extraordinary reason why that's not feasible.

...not sure if all of this is necessary for a Class 1, 510k-exempt device.

Generally, the correct viewpoint is not that low-risk devices can have less labeling than what's specified in the guidances...it's that high-risk devices may need more labeling than the minimum specified.

 

[Ronen E]

Re: Labelling Requirements for Class 1 Device

Hello,

I wonder if anyone can help? I have a medical device - Class 1, 510K exempt. It is a wall-mounted radiographic cassette holder (to be used in an x-ray room only at the direction of hospital staff, obviously).

I'm not sure of the extent of the information our labelling should contain.

I've searched the FDA relevant guidelines but not sure if all of this is necessary for a Class 1, 510k-exempt device. Can someone please help with the FDA requirements for the label to accompany this sort of device? And does the label have to remain with the Medical Device, or actually fixed to it? Or can we just send, as an Instructions for Use type of thing?

Any help at all would be much appreciated!!

Thank YOU!!

Hi,

You could consult the following webpage, all the way down to "Establishment Registration Requirements":

https://www.fda.gov/MedicalDevices/...rview/GeneralandSpecialControls/ucm055910.htm

FDA General Controls are applicable to all medical devices, regardless of class. 510(k) exemption, as far as I understand, is irrelevant to the applicability of other General Controls.

Cheers,
Ronen.