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Comment by eganist | Hacker News Reader

Oof, Rutgers miswrote the entire article. Flagged for being extremely misleading on Rutgers' part (OP only quoted them).

This isn't an approval, it's an Emergency Use Authorization. They're completely different. https://www.fda.gov/emergency-preparedness-and-response/mcm-...

An EUA is specifically to permit unapproved uses in exigent circumstances only. Approval still requires the full workup: https://www.fda.gov/news-events/approvals-fda-regulated-prod...

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@dang, is there value in changing the title from its current state ("FDA Grants Approval for First Saliva Based Coronavirus Test") to "FDA grants Emergency Use Authorization for Saliva Based Coronavirus Test"?

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Edit 2:33pm EDT: calling Rutgers to clarify.

Edit 2:36pm EDT: the appropriate contact for the article has received my message and (as best as I know) is clarifying the release.

Edit 3:01pm EDT: thanks for changing the title, dang!

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YES, please correct the title!

Per an AP article[1] on the confusion surrounding this issue:

> Companies are supposed to state that their tests have not been FDA-approved and cannot rule out whether someone is currently infected.

I see no language like that in the article. But lots of quotes implying efficacy of the test:

> we no longer have to put health care professionals at risk for infection

> we can preserve precious personal protective equipment

> we can significantly increase the number of people tested each and every day

Sadly, I think we are about to see more of this, as companies jump at the chance to get some PR and stock price bump.

[1] https://www.sltrib.com/news/2020/04/12/fears-wild-west-covid...

Is it misleading, or are they just using lay terminology in a press release aimed at lay people?

They were approved to begin emergency use without the usual steps to "FDA approval", correct?

They are using lay terminology, but it doesn’t matter for regulatory affairs: authorization, approval, and clearance are legally distinct and companies are fined for using the wrong word.

Easy english could be a reasonable excuse if the precise terminology would be indecipherable to laypersons, but I don't see that here. "FDA grants emergency use authorization [...]" would give the exactly same diffuse "they allowed something on some level" information to people like me who are unaware of the specifics, but without ruining it for those in the know.

I mean, the subheadline is, in large bold text:

> Emergency use authorization granted for new biomaterial collection approach

They're not hiding anything here, as far as I can tell.

Sure. We've changed the title above.

Appreciate the rapid response here. Thanks!

This seems to be a very specialized use of the term 'approval.'

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