Blame the snake-oil salesmen. It’s mostly their fault that we ended up with so much medical device regulation in the first place.
Back in the mid to late 1800s and the early 1900s, curative “medicinals” and elixirs were all the rage.
With few proven pharmaceuticals available – if any – anyone could produce a magical elixir in their kitchen (or woodshed) and market it in any way they chose.
The Elixir of Sulfanilamide was one such medicinal, marketed as the cure for all pain.
Unfortunately for an unsuspecting public, the elixir was poisonous and resulted in more than 100 patient deaths before being taken off the market.
Turns out the manufacturer knew it was toxic, and agreed to recall the product. However, the sneaky devil only sent telegrams requesting the return of the product, and never bothered to mention that it was deadly.
And that, my friends, is partly what started the push for federal oversight of product labelling – and the requirements for good manufacturing practices (GMPs), as well as a vastly improved and documented product recall process.
The Food, Drug and Cosmetic Act was created in 1938 and amended several times post-inception. In 1976 it was amended again to include labelling of medical devices.
The regulation of medical devices has expanded greatly since 1976, eventually becoming the bane of device manufacturers’ existence while providing job security for regulatory consultants everywhere.
So the next time you are struggling to wade through the fifteen subparts of 21 CFR 820, blame the snake-oil salesmen for your troubles, not your regulatory consultant. We didn’t write the rules. 😁
Much more information about medical device regulation on my website: https://leanraqa.com/
And my YouTube channel: https://www.youtube.com/watch?v=891rHPxAUMQ