You Don’t Need Help With Your Regulatory Submission
I mean, you do your own taxes, and you’re not an expert in US tax law, right?
But if you don’t find, read, and correctly interpret every applicable regulation, how do you know what you’re missing?
Every year the FDA produces more than:
- 400 pages of published guidance documents
- 250 pages of draft guidance documents
- Many pages of consensus standards
- 205 pages of the MDSAP audit guide, plus the companion guide
- 25 pages of ISO 13485:2016
- 225 pages of the ISO 13485 Practical Guide to Implementation
That’s a LOT of reading.
You Don’t Need Help With MDR, Either
If you’re planning on marketing your product in Europe and elsewhere, add these to the mix:
- 175 pages and 11 annexes in the MDR
- Separate medical device regulation for the UK
- Separate medical device regulation for Switzerland
- Individual medical device regulation for other non-EU countries
- Pages and pages of harmonized EU standards
This is where the rubber hits the road, my friends, because that’s more than 1,000 pages of regulations.
Sure, you can find a checklist on some random blog, address those items, cross your fingers, and hope you chose well.
But is that really the best strategy?
Nobody has time for that.
You have more productive things to do, so let us page through the documents to find the regulations, standards, and guidances that apply to your product.
We do dozens of FDA and MDR submissions every year, across multiple markets. No matter your got-to-market plans, we can help you craft a successful submission.
Give us a call. Let us do the regulatory heavy lifting: Perhaps the best decision you make today.
Avoid These Common Mistakes
A few do’s and don’ts and you’re there – easy peasy.
1. Don’t undercommunicate with the FDA – if you need to submit a pre-sub, just do it.
2. Don’t overcommunicate – don’t hand the FDA three presubs when one will do, especially if two of them are unusable
3. Unblock your ears – and listen to what the FDA is telling you
4. Don’t mimic your competitors – worry about your submission, not theirs, and develop your own strategy
5. Don’t try to use political favor or connections to sway the FDA – nuff said.