Classification as medical device or non-medical device?

[Low IQ]

Hi everyone,
Greetings from South Africa.
I currently feel like such an :ca: ! I am investigating the regulatory route possibilities for a newly developed infant apnoea monitor. As a medical device manufacturer our initial thinking was to go the 13485 route, as it is the one we are familiar with. As I understand it, if we classify the product as a medical device it would probably be a class 1(acc. to the MDD). After further investigation it was discovered that similar products, are in fact, not classified as medical devices. We are now considering ISO 9001: 2000 certification as opposed to 13485. After all that useless info here is the question I need answered: What type of certification would we require to market a disposable (product life of approx. 14 months), battery powered non-medical device in the US? Any help would be greatly appreciated!

 

[Asherlee]

Medical device or not

Hi,

From my experience, I suggest that you write directly to the FDA and ask them to confirm that your apnea motor is, in fact, not classified as a medical device, and hence is exempt from a 510(k).

The following link "http://www.fda.gov/cdrh/devadvice/314.html" lists examples of when a 510(k) is not required for devices, but you claim that your monitor is not a device (so I understand).

As you probably know, the FDA published a 510(k) Guidance Document on Apnea Monitors on July 17, 2002; so I think it wise for you to get their official confirmation that your monitor is not classified as a device. Once the FDA exempts your device from a 510(k), they can inform you how to get info. re exporting the product to the USA.

Regards,

Asherlee

 

[Al Rosen]

Low IQ, Asherlee is correct. The FDA classifies Apnea Monitors as class II devices. If your intention is to market it in the US, you will need to meet the FDA Quality System Requirements of 21cfr820.