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[FDA News] Easing the Burden for Small Medical Device Businesses! - FDA's draft guidance document

Date: 2/21/2024

small medical device business

Guess what? The FDA just dropped some exciting news for small medical device businesses! They've released a draft guidance document (HERE) that's all about making life easier when it comes to paying those pesky annual registration fees.


Here's the scoop in friendlier terms:

So, picture this: You're a small medical device company, trying to navigate the maze of regulations and fees. The FDA gets it—they know that these fees can sometimes feel like a big weight on your shoulders.

That's why they're proposing a cool idea: waivers for annual establishment registration fees. Yep, you heard that right! If you're a small business and paying those fees would be a real financial squeeze, the FDA might cut you some slack.

Here's the gist of what the draft guidance says:


  1. Who's Eligible: If your business brings in $1,000,000 or less in gross receipts or sales according to your latest tax return, you might qualify for a waiver. Plus, if you've already registered and paid fees before or you're going through bankruptcy, you could be in luck.

  2. The FDA's Take: The FDA wants to be fair and transparent about who gets these waivers. They're looking at clear signs of financial hardship, like being knee-deep in bankruptcy proceedings. They're all about making sure everyone gets a fair shake.

  3. What's Next: Now it's your turn! Take a peek at the draft guidance and let the FDA know what you think. Your feedback could help shape how these waivers work in the future.


In a nutshell, this draft guidance is like a friendly hand from the FDA, helping small medical device businesses breathe a little easier. It's all about making sure you can focus on innovating and creating awesome products while still staying on the right side of the rules.


So keep your eyes peeled for updates as the FDA gets closer to making this guidance official. It's all about making life a bit easier for you and your business!



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