Regulation ain’t gettin’ any easier
Your medical device regulatory strategy should be similar to your tax strategy: You’re going to pay the taxes, but did you make the best choices to optimize your savings?
You need to make comparable choices for your medical device submission – you need to choose the right FDA product code; you need to determine if your device is a Class I, II, or III; you need to make sure your intended use statement aligns with your classification.
I can see your eyes glazing over already, so why not hand off these key decisions to a team that actually ENJOYS this stuff?
You might even be able to offload most of it!
Intended Use vs. Indications for Use and Why It Matters
Don’t underestimate the importance of your intended use statement. It’s the foundation of your FDA strategy, but too many manufacturers can’t tell the difference between intended use and indications for use. Can you?
The intended use statement refers to the objective intent or purpose for your device, as evidenced by your labeling, your claims, and your advertising. It describes what your product does.
Your indications for use are a subset of your intended use, and describe the target population, duration of use and anatomical location for your device. It describes when and how your product is used.
Clarify your intended use statement first, as it will point you toward the right FDA product code, which in turn helps define your submission strategy. And the right submission strategy can help launch your product on time and on budget.
Did you zone out when I mentioned objective intent? Did I lose you at labeling?
Did I mention that we LOVE this stuff?
Shall I Continue?
No, you get the idea.
I hate to see bad things happen to companies doing good, important work.
In my storied career, I’ve seen one too many “If only we chose that product code” or “if only we followed the procedure” messes that torpedoed otherwise-promising technologies.
Call me so you can avoid the same fate. Please?
How many can you confidently answer?
There’s no harm in not having all the answers. I didn’t – at first. But then I researched the questions thoroughly, spoke directly with the FDA and other regulatory bodies, and I got the answers.
Let me give you the answer key.
1. On average, how many annual FDA regulatory changes should impact my business?
2. I have a 510(k) clearance. What’s next in the commercialization process?
3. Can I use my 510(k) clearance for entry in any country outside the US?
4. What’s the difference between a 510(k) and a technical file?
5. Does my contract manufacturer need to be FDA registered or ISO 13485 certified?
6. Do I need a quality management system if my contract manufacturer is FDA registered and ISO 13485 certified?
7. What types of ISO 13485 certifications are there? Will my selection impact which markets I can enter?
8. What are the differences among class I, II, III, and unclassified devices?
9. How do I know which device classification I am?
10. How many FDA submission types are there? Which one is best for me?
11. What is the difference between intended use and indications for use?
12. How do I choose the best FDA product code for my product?
So how’d you do?
Rank your performance:
🌟 10: You’re a superstar.
What are you doing here? You’ve totally got this.
💪 9: Impressive!
How I can complement what you’re already doing?
😬 8 or fewer:
To be safe, put time on my calendar. “Too proud to ask Michelle” is no reason for a 483 or warning letter. Plus I like meeting new people!
Help Has Arrived!
Pick an open half hour on my calendar.
Maybe I can lighten your workload and I would LOVE to help!
