FDA Classification for Medical Device Power Adaptors (Power Supplies)

Hi All,

Anybody know how the medical adaptor (power supply) be supervised by FDA?
Does medical adaptor (power supply) be included in the defination of medical device?

I have checked the database of classification from the FDA website, however, there is not suitable classification for power supply, I wonder if this device is supervised by FDA?

Can someone help?

Thank you!!

Stijloor.

yarina said:

Hi All,

Anybody know how the medical adaptor (power supply) be supervised by FDA?
Does medical adaptor (power supply) be included in the defination of medical device?

I have checked the database of classification from the FDA website, however, there is not suitable classification for power supply, I wonder if this device is supervised by FDA?

Click to expand...

Another quick bump....

yarina said:

Hi All,

Anybody know how the medical adaptor (power supply) be supervised by FDA?
Does medical adaptor (power supply) be included in the defination of medical device?

I have checked the database of classification from the FDA website, however, there is not suitable classification for power supply, I wonder if this device is supervised by FDA?

Click to expand...

2 clarification questions:

1. Is this power adaptor sold (placed on the market) on its own, or as part of a system / another device?

2. Is this adaptor intended specifically for a certain device? If so, does this device have alternative adaptors available on the market?

Ronen E said:

2 clarification questions:

1. Is this power adaptor sold (placed on the market) on its own, or as part of a system / another device?

2. Is this adaptor intended specifically for a certain device? If so, does this device have alternative adaptors available on the market?

Click to expand...

These follow up questions will help us understand the scenario. We are unable to supply further comments for the original question on FDA Classification for this power adaptor. However, if you really would like to get better understanding on FDA classification for this particular product, you can rely to link removed as I have seen they can answer your question. Hope it helps.

This adaptor will sold on its own, it is supposed to be used for other medical devices with proper specifications. It is not for certain device.

Thanks JohnJohnson, however, the website you pasted can not be opened.

yarina said:

Thanks JohnJohnson, however, the website you pasted can not be opened.

Click to expand...

I also checked the page for FDA classification for medical adapter. I also came across this: http://www.fda.gov/Safety/MedWatch/ucm239820.htm.

yarina said:

This adaptor will sold on its own, it is supposed to be used for other medical devices with proper specifications. It is not for certain device.

Click to expand...

Then I currently see no reason to classify it as a medical device, or an accessory to one; as such it would not be subject to FDA regulation.

What makes it "medical"?

The classification rules are nor very clear for specific items.

From experience, I can tell you that if an item, in this case the power adapter, is essential for the whole medical device to achieve its main therapeutic purpose, then the power adaptor is part of the medical device.

Not a medical device per se, but part of the medical device, and as such, should be considered at least at a system level for risk management, V&V and manufacturing controls. Even if it is an off-the-shelf item, a safe approach to avoid regulatory challenges would be that.

I hope this helps.