Turns out the Drood & Fug has a pretty nice nature path on the premises.  The D&F campus used to be a Naval Research Center, so there's a good buffer zone of woodland around it that used to allow the Navy to do whatever X-Files weirdo testing they wanted to do here without detection.

However, it also turns out that the nature trail is closed due to ( Read more... )

Manager: Starting this week, we will have a new intern.  Her job will be to try to straighten out the GEI device classification.  We try to do this every year or so.  It never works.  It's a mess.  We'll try again, and it probably won't work.  It's impossible.

Me: You know the new intern is sitting right next to you, right?

Somewhere in Australia, there's a post doc that's researching the possible adverse events of an odd piece of sports medicine equipment ( Read more... )

Dear CORRESPONDENT:

Regarding the rejection letter you recently received from FDA -  the only document that this could be referring to would be the letter sent to FDA to confirm that you are the official correspondent for MANUFACTURER.  Since you received the notice that the confirmation letter was rejected, it shows that the confirmation letter ( Read more... )

I just had a meeting with this guy.  He's the director of medical devices at my agency, and is at least five levels above me in the organization chart.  He called a 1-on-1 meeting with me after I made some suggestions on how to improve our customer service initiative ( Read more... )

I'm reviewing the 2nd submission in a row that has important information in the Executive Summary that isn't found anywhere else in the submission ( Read more... )

It looks like they are very serious about tracking our hours during the shutdown. (To recap: I'm marked as 'essential'. Not because my job is life-or-death, can't stop for a few weeks important, but because we had a stash of outside funding) We have to fill out an online accounting of hours on our patchy effort reporting system. Normally, this ( Read more... )

It's 1:00 AM, and I'm just getting home from work. I've been working on a HUGE submission for a new medical device. Like, four crates of volumes huge. And not only is the submission huge, it is also a huge, stinkin' concern for the FDA. Our upper brass are heavily focused on this company right now. In fact, the head of all Medical Devicedom at ( Read more... )

All of my working extra hours has made me eligible for a recognition award at work. Unfortunately, due to the sequester, cash awards have been eliminated. Now they only award extra time off ( Read more... )

The American government is going to increase the regulation of blood lancets. I just got back from a panel meeting where the FDA, the CDC, the doctors, and industry and patient representatives agreed unanimously to do so.

We are doing so mainly because assisted care facilities SUCKLancets are the little needle assemblies used by diabetics for ( Read more... )