"Under its Accredited Persons Program, the FDA must review and respond to 510(k) submissions from authorised Third Party organisations within 30 days of receipt. The review timeline for direct 510(k) submissions to FDA is 90 days beginning from the date of the initial submission."
"Please note that FDA does not perform 510(k) pre-clearance facility inspections. The submitter may market the device immediately after 510(k) clearance is granted. The manufacturer should be prepared for an FDA quality system (21 CFR 820) inspection at any time after 510(k) clearance."
21 August 2017
ASX ANNOUNCEMENT
Heart Failure 510(k) Application for SOZOTM Submitted to FDA
Imminent news ???
today's jump up, page-33
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