Labeling MR safe & MR Unsafe (magnetic resonance imaging topic)

A

Anoniem

#1
We would like to start selling our MR safe and MR unsafe devices in the USA and are writing the 510(k).

The MR safe / MR Unsafe logo and explanation is already in the Instructions for Use. Do we need to place the MR safe and MR unsafe logo on the productlabel (sticker)? And also on the box (packaging)label?

Our productlabel stickers and boxlabel stickers are only black/white, we cannot change that. Can we change the official MR logo's into a black/white logo?

I would appreciate your help, thank you!
 
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M

MIREGMGR

#3
Re: Labeling MR safe & MR Unsafe

The discussion is about magnetic resonance imaging. Devices and accessories used within a relatively large zone around the MRI magnet, if they are ferromagnetic in physical chemistry, will be magnetically attracted and may impact the patient or clinical personnel as they accelerate toward that MRI magnet.

FDA has a guidance on MR safety--http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm107721.htm--and also at least two other documents that pertain to MRI safety and effectiveness, including http://www.fda.gov/downloads/medicaldevices/newsevents/workshopsconferences/ucm284019.pdf and http://www.fda.gov/downloads/medicaldevices/newsevents/workshopsconferences/ucm283551.pdf. FDA also recognizes four ASTM standards--F 2503, F 2119, F 2213 and F 2052--that call for MRI devices and accessories to be evaluated by means of testing or engineering analysis as to MRI suitability, and labeled as either MR safe, MR unsafe or MR conditional using standardized graphics.
 
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M

MIREGMGR

#4
Re: Labeling MR safe & MR Unsafe

The MR safe / MR Unsafe logo and explanation is already in the Instructions for Use. Do we need to place the MR safe and MR unsafe logo on the productlabel (sticker)? And also on the box (packaging)label?
ASTM F 2503, which is authoritative on MR safety marking, says to mark on the device itself if possible, and on the labeling. The IFU is labeling, so you meet that latter minimum requirement. There is no mention of marking on the box.

Our productlabel stickers and boxlabel stickers are only black/white, we cannot change that. Can we change the official MR logo's into a black/white logo?
Per the above standard, yes if necessary, but "the use of the colored icon is strongly encouraged".
 

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Trusted Information Resource
#5
Re: Labeling MR safe & MR Unsafe

MR = Magnetic Resonance, MRI = Magnetic Resonance Imaging

FDA refers to ASTM F 2503 for the labeling regarding MR; under 7.1 this standard calls for symbols on the package labeling and states that "if color reproduction is not practical, the the icon may be printed in black&white"
 
A

Anoniem

#6
Thank you very much for your clear and quick answer. We will print the instructions in colour and the productlabels in black/white. Boxlabels we still think about.

Thank you again!
 
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