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Ann: RAP Licenses Additional Pneumonia Diagnostic from UniQuest, page-159

Currently unlisted. Proposed listing date: 4 SEPTEMBER 2024 #

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shaunstewart1

168 Posts.

21

03/05/17

15:34

Post #: 24443907
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Originally posted by shaunstewart1 ↑

I agree with your analysis CT,

I think one thing holding them back from establishing deals with Telehealth partners embedded with the clause 'subject to FDA approval' is because they cannot actually market without FDA approval?

From the De Novo Guidance:

If the submitter demonstrates that the criteria at section 513(a)(1)(A) or (B) of the FD&C Act 101 are met, we will grant the de novo, in which case the specific device and device type is 102 classified in class I or class II. The device may then be marketed immediately
(bold my own)

Expand

...If the de novo is declined, the device remains in class III and may not be marketed.

https://www.fda.gov/downloads/Medic...onandGuidance/GuidanceDocuments/UCM273903.pdf
page 5 section 3

Last edited by shaunstewart1: 03/05/17

RAP Price at posting: 31.0¢ Sentiment: Buy Disclosure: Held
1 Upvote

0 Great analysis

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