Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
CDRH's Kessler on public radio: "Stents are fantastic inventions by medical device companies. I just don't think that the public has any clue that this industry is out there. People talk - with all respect to my sister agency - drugs, drugs, drugs and those are wonderful, but there is technology out there that is really working and the medical device field is outstanding," Office of Science & Engineering Laboratories Director Larry Kessler remarked during an Oct. 6 Kojo Nnamdi Show highlighting the CDRH science office. Later, Kessler alluded to fake Prolene surgical mesh manufactured by a company in India. OSEL testing found that although the counterfeiter's attempt at the J&J product did have some sterility problems, it largely worked as intended. Kessler also discussed timing for OSEL research: "We try to start studies that we do that are going to reflect products that come into the agency for approval anywhere from one to as much as five years ahead of time." Kessler added: "We have been doing a lot of work, for example, in laser diagnosis - that is, using light to diagnose conditions. We are trying to really move ahead, and some of these studies take six months to a year, sometimes two" years...