Category Archives: Strategy vs. Tactics

Tips for Preparing a 510(k) Submission

The past few weeks have been super hectic and crazy busy. I've been up to my eyeballs preparing a 510(k) submission for a startup. Good news is that it is sitting on my desk right now and is ready to ship to FDA. The device is relatively simple and straightforward. The submission is too, yet still comes in at ~200 pages. As I look at the stack of paper sitting on the desk, I begin to wonder if this is how a novelist feels right before sending a manuscript off to be edited. I'm anxious, excited, and a little bit nervous. Regardless, the submission will be boxed up and shipped this week. And in about 2 - 3 weeks from now, we should get work from FDA whether the 510(k) has been...

Why Ignore FDA?

A couple weeks ago, I shared a story about a medical device company seeming to not take FDA 483 observations very seriously. I learned recently, they have done little in the past month to address the identified shortcomings. At first this really bothered me. How could a medical device company be some nonchalant and complacent regarding FDA observations? Seems like you would want to fix the issues as quickly as possible. This medical device company has a different philosophy though. And I really saw this come to light a few weeks back. When they basically ignored the commitment they made to follow-up with FDA by May 1, the signs were apparent. I was given the responses ". . . I've been too busy to deal with FDA stuff ....

I’m Just Too Busy. I Don’t Have Time.

Yeah, I've said this before. And this response is so generic and meaningless. Of course we're all busy. Yes, there never seems to be enough time. As a consultant working with medical device companies to implement solutions, from time to time, I need the company's resources to participate in the activity. I need the resources to review the procedures, forms, etc. I am proposing. I even sometimes need their assistance implementing. I realize that sometimes I am suggesting a change to their comfortable, busy life. However, when we are brought in to identify opportunities for improvement and implement, I need you to find some time to be part of the solution.  ...

Why Would A Medical Device Company Take FDA 483 Observations Lightly?

I wish the tale I'm about to share is hypothetical. It's not, however. Several months ago, I was contacted by a small medical device company. The initial conversation led me to believe the company was being somewhat proactive about making improvements to its quality system and internal processes in the spirit of continuous improvement. The company asked me to provide a proposal to revise their QS. A few weeks went by. The only update provided was the proposal was being reviewed and discussed by the board. Weeks turned into months. No decision. And then FDA came in for a visit, almost three years to the day from the last FDA inspection. I was asked to participate in the closing meeting. No surprises from FDA. All the 483 observations had been identified by me and others...