Compliance In Focus

Currently, trial results for are only required to be submitted to the online database for cleared or approved devices.  However, a November 19th proposal from the National Institutes of Health which would require trial results and descriptive information for devices and device indications that have yet to be cleared or approved by FDA would be posted on the public ClinicalTrials.gov website.  The proposal would give trial sponsors up to three years between the completion of the trial and when results need to be submitted to NIH if they are legitimately working towards reaching the market.

When is emergency use of unapproved devices acceptable?  The Federal Regulations explicitly state how an unapproved device should be used in an emergency situation by a physician. The FDA website also provides a training presentation on this topic.