Titan Medical Inc (TMDIF)

[RockoTaco]

Foreign companies/studies
Can a foreign company submit an IDE/Is a U.S. Sponsor required?

A foreign company cannot sponsor an IDE; the company must have a U.S. agent who acts as the sponsor (see 21 CFR 812.18(a)). The U.S. agent must fulfill all the responsibilities of a sponsor identified in the IDE regulations.

Do clinical studies have to be conducted in the U.S. / Will foreign studies be accepted?

The FDA continues to promote global harmonization in many aspects of medical device development and regulation, including our commitment to recognize the value of and accept, where appropriate, data from multiple sources and countries.


SO THE QUESTION IS, WHO IS SPONSORING TITAN MEDICAL?