Happy 40th Birthday Medical Device Amendments – You’re Officially Over-the-Hill

May 26, 2016


By Allyson B. Mullen & Jeffrey N. Gibbs

Oh Medical Device Amendments how we love thee. This Saturday marks your 40th birthday.  In light of this momentous occasion, we wanted to wish you a very happy birthday with a blog post all your own. 

In 1976, Gerald Ford was President, the U.S. celebrated its 200th birthday, the average price for a gallon of gas was 59 cents, and you and the $2 bill were born. We are so glad that you’re more popular than the $2 bill! 

You were born with the cutest little definition:

“an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

  • recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
  • intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
  • intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.”

Your parents thought this definition would simplify life for everyone. Sometimes, though, you can’t always get what you want.  No one ever could have dreamed of all the controversies your “primary intended purposes” and “chemical action” phrases would spark years later. 

And, to be honest, some of your other provisions have been a bit cryptic. We’ve spent many confounding years working on mysteries without any clues.  Expecting you to make perfect sense was to dream the impossible dream.  You’ve always surprised us with your complexity.  You started off as an adorable little law.  As we examined you more closely, we saw how multi-dimensional you were, bigger on the inside than the outside. 

You were never a quiet, sleepy child. You got down to work right away.  Baby, you were born to run. 

At first, things didn’t go so smoothly. When you were seven, you were even called FDA’s Neglected Child.  But nobody can call you that now.  Now, the Law is not mocked. 

You grew up quickly, and started confusing your older sibling, the drug industry, with your crazy new regulatory pathway, the 510(k) process. Who would have thought that out of all of your carefully crafted text, one tiny provision would have led to the most utilized regulatory pathway for medical devices and one of the most important provisions in the entire law?  But just like a little Hobbit overthrew a mighty sorcerer, this one seemingly insignificant paragraph upended the whole device regulatory regime.  Did anyone think about this when they wrote the Law?  We don’t know.  We weren’t in the room where it happened.

Even though you’re entering your fifth decade, we love that you are still trying to figure out who you are. We’d give you advice but children won’t listen.  Is a product a device if it is not treated like one? 

Really, what is a device? 40 years and still no one knows exactly!  Do you encompass laboratory developed tests, clinical decision support software, a product that contains a little chemical action (but not too much), some other cool new device we haven’t even thought of yet?  And that’s without mentioning your half-sibling, “enforcement discretion.”  Maybe.  As you wish.

Sometimes, we do wish you’d just find yourself and settle down. But recently, it seems every 5 years you go through another growth spurt.  You never can just let it be.  In fact, it looks like you’re due for another big change next year. 

Even now, you’re full of surprises. After banning just one device in 40 years, you proposed two bans just this year.  Suddenly, it’s banned on the run. 

One thing is for sure; you’re never boring. We can’t wait to see what the next 40 years brings.

Happy Birthday!


HPM’s Device Group

PS: Since we couldn’t sing you a happy birthday song, we’ve sprinkled some references to music in this note.

Categories: Medical Devices