Titan Medical Inc (TMDIF)

[66Mustang]

IDE approval is done by the FDA so you are technically correct in that statement of "IDE approval is FDA approval." But it isn't 510k approval which says its okay to market the device.

Realize also that the IDE approval requires the applicant to meet 90%+ of the criteria for final 510k approval to market the device (safety. efficacy, etc.). The only real difference is the 510k approval also requires reports from the IRB to be reviewed by the FDA. With Colombia's likely involvement and possibly lead role in the IRB investigation and generation of those reports (with Dr. Advincula possibly at the helm), how bad could that last 10% be?

The IDE application is a milestone event. The IDE APPROVAL is possibly the most CRITICAL milestone event of this product's timeline.



Message in reply to:
RockoTaco
Monday, 09/16/19 05:29:40 PM
Re: Honeycomb777 post# 96079
Post # 96082 of 96096


IDE approval is FDA approval

https://www.fda.gov/medical-devices/device-advice-investigational-device-exemption-ide/ide-approval-process

Studies of devices that pose a significant risk require both FDA and an Institutional Review Board (IRB) approval prior to initiation of a clinical study. FDA approval is obtained by submitting an IDE application to FDA (§812.20)