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A comment on Nearly 400 medical devices, procedures and practices found ineffective in study. Parent comment

Re:Nearly 400 medical devices, procedures and practices foun... by gumby on Thursday June 13, 2019 @11:15AM (#20175649)
This. Having been through the FDA process myself (though we didn't make it to NDA, sob) I have to say that dealing with the Agency was great. Tedious, but great, and nothing seemed stupid except some trivialities at the margin (e.g. certain formatting issues).

Honestly the worst parts of dealing with them are direct consequences of people trying to game the system. We went out of our way to make sure nothing we did could give that impression and got excellent guidance and response.

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Re:Nearly 400 medical devices, procedures and practices foun... by bilbo0s on Thursday June 13, 2019 @12:19PM (#20176310)
Same.

Been through that process with a couple products from a medical imaging software startup. Extreme professionalism and competence was the lasting impression I got from my time interacting with them. We were making software that could be used in oncology for diagnosis, analysis, and treatment planning, so yeah, we got the regulatory proctology exam. But I wasn't annoyed at all. They were highly competent people who took their duty to protect the public from me seriously.

I took no offense at all.

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Re:Nearly 400 medical devices, procedures and practices foun... by abrichr on Thursday June 13, 2019 @07:59PM (#20179613)
Sounds interesting! Which startup?
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