3 min reading time

I’ve been hosting 10x Medical Device Conferences for six years but no one – before Bob Marshall – sang on stage.

You likely recognize Bob’s name if you subscribe to his extremely popular Med Device Online site where he serves as Editor in Chief.

I cite the lyrics below. But you’ll want to hear it for yourself. While you’re there, pick up his FDA guidance slides and the transcript.

I had a pre-submission meeting
so I went down to Silver Springs.
I took documents, and drawings,
and lots of other things.
They said, “Go home, boy.
Wait until the telephone rings.”

I got the Regulatory Blues.
About to lose my mind.
I’m waiting on some data
no one can seem to find.
Now my 510(k) submission
is running three months behind.

I got a call last week.
Said they were coming for an inspection.
Someone down at the hospital
got a real bad infection.
Now they’re telling me
I got to recall the whole collection.

Tried to renew my registration.
I just sent it in the mail.
Because every time I went online,
their website would fail.
Now they’re putting me in handcuffs,
and taking me to jail…

Some key takeaways

Or should I say, “on key takeaways.”

Get it? On key? Because he sang?

🙄 Oh, forget it. 🙄

• Patient population splits. “For a long time in clinical trials, we’ve not done a good job covering gender, ethnicity, and other issues in having a good population to represent the end users.” FDA gives us guidance on that now.

• Is it a device? FDA realized some previous guidance was going to be problematic, specifically related to things around chemical action. They initially said, “There can’t be any chemical action or it’s not a device.” In this guidance, they’ve backed off.

  Now they ask, “Is the chemical action coincidental or is it the main part of how the results are achieved?”

• Submissions involving cybersecurity. They’ve given us guidance. They want to know your ‘updates over time’ plan because software changes all the time. You need to tell them how you’re planning for it.

• Medical device accessories. FDA is looking at them differently now. This post is getting long so click through for more information, including what Bob calls “Coming Distractions.”

Nice job, Mr. Marshall. Thank you for sharing with the Group.

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That Packard webinar

Rob knocked it out of the park in our “How to prepare a 510(k) submission” presentation last week.

As promised, here are the slides.

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Candidates, search medical device jobs and sign up for job alerts at https://medgroup.biz/jobs.

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Discussions You May Have Missed

Ask your question at medicaldevicesgroup.net/question/add.

Juan Ángel Gracia García, Technical Director Medical Device Department, asks, “Chemical peels: cosmetic, medical device, drug… or what?”

Kasper Friis, Head of UX & Design for Technolution A/S, seeks your feedback: “How do you make sure that people will love your product?”

Ruth Clark, wonders “Which medical products are made from fabric/textiles?”

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Thank you for being part of our Medical Devices Group community!

Make it a great week.

Joe Hage
Medical Devices Group Leader

P.S. This is your community as much as mine. Please, write me if you’d like to contribute an article or ask a question.