Last week there was a guest post / interview with Bennet Dunlap from Your Diabetes May Vary the FDA. As promised, Bennet was going to answer a few follow up questions from you all and also add some additional details to a few things he spoke about last week. Since a lot of this FDA stuff can be overwhelming, I am breaking this follow up into two separate parts, today and Monday. There are a lot of links here, so I suggest that you open them all up and then bookmark them or just bookmark this post and come back to the next link after you were able to read through the previous one. Well, let’s get to Bennet’s additional answers.
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First up, we received the following tweet from @Wyld_Celtica_V : @LifeofaDiabetic @BadShoe Why do the EU get new & very nice tech before us? If it clears THERE, why not Here in the US? #FDA
Great question.
Here is the readers digest version:
The regulators are looking to different standards and used different processes to meet those different requirements. In short, in the EU a device must be shown to be safe and in the USA it has to be safe and effective. I have heard some say the EU model puts more of the responsibility of choosing an effective device on the physician.
In addition there are non governmental bodies that do the regulatory reviews in the EU and the US it is a governmental body, the FDA that is responsible to review device applications.
In summary:
- The US process looks at both safety and efficacy and so takes longer
- The FDA does the reviews in the US where as non governmental groups are used in Europe.
- The US takes longer
- Device manufacturers are legitimately interested in getting returns flowing to pay for the cost of developing a device. They may see Europe as a faster means to starting to pay off R&D costs.
For more information you can look at these resources:
- http://circ.ahajournals.org/content/109/25/3068.full
- http://blog.sstrumello.com/2012/08/why-pharmamed-device-cos-apply-for.html
- http://www.mddionline.com/blog/devicetalk/op-ed-clinical-testing-medical-devices-europe-versus-united-states
Are there more resources for learning about what is going on with diabetes and the FDA?
Yes. The media relations folks at FDA shared a page with a few links:
http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/DiabetesInfo/default.htm
Once you have a few set up it is easy to customize the subscription you want at:
https://public.govdelivery.com/accounts/USFDA/subscriber/topics
I am curious about what a review of an issue with the FDA may look like, do you have an example.
Sure do. Here is a 29 page FDA Guidance document that is about Mobile Medical Apps:
**Here is Bennet’s comment on it: http://www.ydmv.net/2012/08/the-fda-comment-that-got-away-or-maybe.html How could we use that to comment?
The next step would be to draft and collect a few form letters. Bennet & other are willing to do that. Then folks can customize those letters with personal information and send them to their congressional representatives and to the FDA.
**Bennet has worked up a few draft letters and they are posted at the end of the page on the link above.