K
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!!
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!!