3 ms·
I get the satire and I hate to be pedantic… BUT The phrase “safe and effective” has a legal meaning and only applies to (1) drugs and vaccines, (2) high risk m
by pfisherman 4y ago
I get the satire and I hate to be pedantic… BUT
The phrase “safe and effective” has a legal meaning and only applies to (1) drugs and vaccines, (2) high risk medical devices, and (3) novel medium risk medical devices.
The phrase “safe and effective” notably does not apply to the practice of medicine, which is not regulated by FDA. When it comes to medical practice, you are usually speaking in the language of (CMS) quality / value - “quality adjusted life years” - and then clinical endpoints - blood pressure below X.
I know this is being pedantic, but as someone who has had an up close view of FDA regulatory policy / process from both sides of the table, it literally hurts my head to see some of the inaccurate and misguided stuff that gets bandied about on the interwebs.