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Monday, November 26, 2018 11:39:26 AM
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm626572.htm
On a scale of 1-10 I'm going to rate this a bigly. Possibly a happening. I don't know someone check me.
We believe that where appropriate, new medical devices that come to market under the 510(k) pathway should either account for advances in technology or demonstrate that they meet more modern safety and performance criteria.
Ok so if I`m just some nobody printing a plastic spinal implant off my 3d printer the door looks closed to me starting a company based on this level of tech.
Our Women’s Health Technologies-CRN https://bit.ly/2L4Tqsx is providing evidence on device therapies unique to women - uterine fibroids, pelvic floor disorder, female sterilization and long-acting reversible contraception.
https://twitter.com/SGottliebFDA/status/1066722401231269894
He's taking shots at the other issue brought up in the Bleeding edge doc about women's health devices, in my opinion. What litmus test are we using to declare this as a definitive response to the bleeding edge doc? What litmus test where we using against the Sonny and Hanson exchange about "playing to win" to prove that was really real? NONE. too many factoids being dropped here to analyze and correlate to the rest of the data. I can only show you the door at this point.
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