Replies to post #11340 on Imaging Diagnostic Systems (fka IMDS)

[LongnShortOfIt]

You're wrong!

Here's the flippin LAW!!

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=314.430

(b) FDA will not publicly disclose the existence of an application or abbreviated application before an approval letter is sent to the applicant under 314.105 or tentative approval letter is sent to the applicant under 314.107, unless the existence of the application or abbreviated application has been previously publicly disclosed or acknowledged.