FDA proposing to regulate medical device accessories based on the risks they present when used as intended with their parent devices and not based on the risks of their parent devices. For example, if a parent device warrants regulation as a Class II device but an accessory to the parent device presents lower risks, FDA would regulate the accessory as a Class I rather than a Class II device.
This could be helpful and useful to a lot of manufacturer's..
Read more HERE
This could be helpful and useful to a lot of manufacturer's..
Read more HERE


