Exclusive: A U.S. lawmaker involved in health policy has asked the Food and Drug Administration why it did not inspect Elon #Musk’s Neuralink before allowing the brain implant company to test its device in humans. https://www.reuters.com/business/healthcare-pharmaceuticals/us-lawmaker-seeks-answers-fda-inspection-musks-neuralink-2024-03-26/
@GottaLaff@mastodon.social That is a very good question - the Human Subject Research regulations prohibit that
@GottaLaff@mastodon.social
Yep. The rest of the medical community would like to know that, as well.
@GottaLaff@mastodon.social
I think the FDA is ill equipped to be the Tech Admin.Their answer should have been “umm no. You’re thousands of living monkeys away from human testing”
@GottaLaff
Lots of questions@mloxton We need lots of answers.
@GottaLaff@mastodon.social
I think I know the answer to the main question, and it is a bit boring.I expect that Neuralink got approval for human testing because they used a “same as” application, and could cite many other very similar implants that had been previously approved for other applicants. (2002, 2006, etc)
I want to know how this patient selected, the end points, what is this “issue” that the patient mentioned, what outcomes and adverse effects are being monitored, what are the rollback options?
