As a scout we had a very functional organization. We worked in patrols, we had an assistant Patrol leader and a patrol leader. They got together with other leaders and executed decisions made be the s...

As a kid I was in the Boy Scouts. We had 4 different patrols, each with a Patrol Leader and his assistant, and then there was the Senior Patrol leader with his two assistances. Even though there was n...

I think there are pieces from every post before mine that are critical in what should be included. I agree, to an extent, with what all of you have had to say. I think it needs to be improved by manag...

I would still say no, the fitbit does not need to be regulated. The CDRH defines a general wellness product as “Products that are intended for only general wellness use and present a low risk to the s...

Going in line with the example in the question, there are different coating on implants used to stimulate specific responses. For example the Hydroxyapatite coating on a titanium implant to convert fi...

The Lifevest would have to be a Class III because it has the potential to save a life, though is a great risk to the wearer. Because the response of the mechanism is based off the persons heartrate, t...

I am a little torn on this. On one hand, I believe they are different and yet on the other I say not. Project managers are in charge of obtaining the end, desired result. This is alike for both profes...

I may be going out on a limb here, but I think board games could be considered something of a general wellness product. It would be of the first category because games don't reference diseases or cond...

I agree with what has been stated before me. I do not think the Fitbit should be considered for FDA approval; as it does not make any medical claim. This function of the watch is merely there for conv...