Watchcat
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I'm interested in hearing from those of you who have put the same medical device on both the US and EU markets within a reasonably short period of time, e.g., < 2 years, without using MDSAP.
How did the actual regulatory costs (e.g., FDA registration fee and filing fee, versus NB fees) compare? Was one noticeably more expensive than the other, or were they about the same? If so, which one was noticeably more expensive?
If you reply below, please include 1) the device class in the two jurisdictions, 2) the FDA pathway, 3) the EU Directive or Regulation, 4) approximate timeframe (eg, in the last 5 years vs, early 2000s), and whether this was a startup situation (e.g., new FDA establishment registration, new NB) or an add-on for an established company.
I do not need, or especially want, to know the company, the device, or other such touchy details.
Alternatively, feel free to message me or email me directly:
julie(at)class3devices(dot)com
Thanks in advance! If I get enough replies to learn something, I will share what I learned, as always.
How did the actual regulatory costs (e.g., FDA registration fee and filing fee, versus NB fees) compare? Was one noticeably more expensive than the other, or were they about the same? If so, which one was noticeably more expensive?
If you reply below, please include 1) the device class in the two jurisdictions, 2) the FDA pathway, 3) the EU Directive or Regulation, 4) approximate timeframe (eg, in the last 5 years vs, early 2000s), and whether this was a startup situation (e.g., new FDA establishment registration, new NB) or an add-on for an established company.
I do not need, or especially want, to know the company, the device, or other such touchy details.
Alternatively, feel free to message me or email me directly:
julie(at)class3devices(dot)com
Thanks in advance! If I get enough replies to learn something, I will share what I learned, as always.