Compliance In Focus

You may have heard the term Sponsor-Investigator before, but just who are they and what do they do?  Just as the title suggests, a Sponsor-Investigator is someone who both initiates (sponsors) and conducts (investigator) an investigation.  This may sound simple, but in actuality, the role can be quite complicated.  However, like anything else, with proper preparation and support it can be accomplished.  Sponsor-Investigators are a rare breed of extremely intelligent, hardworking people who are on the cutting edge of scientific advancement in their respective fields.  They are so committed that they are willing to do essentially twice the work to bring new technologies and advancements to the medical community.

FDA recently published a new proposed rule in the Federal Register that will be open to comments until May 28th, 2013.  The rule proposes an amendment to the regulations at 21 CFR Parts 807, 812, and 814 pertaining to the acceptability of data collected inside and outside of the U.S. that will be used to support a marketing application (IDE, 510(k), PMA, etc.).  Surprisingly, the regulations currently do not fully address the requirements for either.