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4 min reading time
I know a guy who got a $500,000 grant to make FDA data easier to search. As it neared completion, it was scuttled by two employees whose jobs would be jeopardized.
So the answer to “which is the most frustrating FDA database” is probably:
I think I found a solution and I’m inviting you along to discover it with me.
If my understanding of the product is right, compiling and analyzing FDA data will be so much easier.
Navigator from Reed Tech
I signed up for a product demo and set it up so you could join me on the call. Please join me for the live demonstration.
It will be on December 11 at 2 p.m. Eastern Daylight Time, recorded for later viewing.
Navigator saves search time and effort
Again, as I understand it, Reed Tech built a platform to make using FDA data much easier. They pull in data from:
• MAUDE (adverse event reporting)
They also use data from the GUDID and device listings databases behind the scenes.
What’s the big deal?
If you routinely access FDA databases, you know it’s a hassle searching multiple sites and matching the data up get a holistic view of the issue.
Navigator lets you look up by product to get everything you need: Adverse events, recalls, approvals and clearance information associated with that product. You can also compare to the industry for all those data points.
If you don’t use FDA databases, here’s how that data can help you:
FDA data is more than regulatory and quality
Other uses for FDA data:
Legal and Insurance. For product liability and product lawsuit research. Is this a product they want to insure?
Medical device investors. For due diligence. Anything lurking there in product quality? Industry trends?
Healthcare providers. For due diligence. Anything you should know before you approve that capital investment? Are you sure the product has been cleared by FDA? Are there any active recalls in that category? Any usability issues?
That registration link again
If you’d like an easy way to use FDA data, click here to join our call.
Special thanks to Rachel Benway for the education.
I’m looking forward to the demo and I believe Reed Tech will be at the 10x Medical Device Conference in May.
Three FDA Safety Stories
Thanks to Robyn Barnes and Ken Smyth for bringing these to my attention.
In Other News: Crispr Babies!
After regular IVF (after sperm inseminated eggs), an embryologist sent in CRISPR/Cas9 protein and instructions to perform a gene surgery intended to protect the girls from future HIV infection.
As I understand it, it’s the first reported case of gene surgery in embryos intended for pregnancy.
Thank you for being part of our Medical Devices Group community!
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Make it a great week.
P.S. I probably spent more time on this post (eight hours?) than any in my seven-year history with the Group. If you appreciate it, email me or – better yet – spread the word! Tell colleagues to join our community. Invite them to the December 11 webinar, perhaps!
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