Medical Device Link.

Last July, Alberto Gutierrez, PhD, was appointed the new director of the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD). According to OIVD officials, Guttierez’s appointment is effective immediately. He took over the position that had been vacated by former director Steven I. Gutman, MD, PhD, who stepped down last year.

Gutierrez received a bachelor’s degree from Haverford College, and master and doctorate degrees in chemistry from Princeton University. He has more than 10 years of experience in research in the area of structural organic and organometallic chemistry. In 1992, he joined FDA as a researcher and reviewer in the agency’s Center for Biologics Evaluation and Research, working on vaccine adjuvants and method development for determination of purity and structure of vaccine components. In 2000, he first joined OIVD as a scientific reviewer, becoming a team leader for toxicology in 2003, director of the division of chemistry and toxicology devices in 2005, and deputy director for new product evaluation in 2007.

Gutierrez told IVD Technology that the following are some of the goals he plans to focus on as the director of OIVD: navigate as smoothly as possible through the regulatory challenges that personalized medicine will present; be an active participant in finding solutions to a dual regulatory path ensuring public health while creating a fair process for IVD manufacturers and laboratories; continue to develop the seamless integration of premarket, postmarket, and compliance information and functions that are at the core of OIVD; improve guidance and regulation development; continue to find ways to improve on a climate of transparent decision making; and recruit, develop, and retain high-quality staff so that OIVD’s decisions continue to be based on science

Industry analysts believe that Gutierrez and OIVD have several pressing issues they will have to start addressing immediately. Some of the more critical matters include the
following.

According to analysts, OIVD needs to improve the transparency and predictability of the diagnostic review process. It is important for both OIVD reviewers and IVD manufacturers to understand what is required during the review process and then work together on getting an application containing the required data to move quickly through the process. The review process also needs to be more closely tied to the risks presented by the IVD product for its intended use.

“A big challenge is the accelerating regulatory creep at OIVD,” says Brad M. Thompson, JD, of Epstein Becker Green (Washington, DC). “Our analysis shows that during the last couple of years, the time it takes to get products cleared by OIVD has steadily increased. Furthermore, and much more significant than the actual review time, there has been a dramatic increase in the amount of data FDA expects for clearance or approval. At a time when people need better access to healthcare, this ratcheting up of approval requirements is delaying some important IVD technologies.”

Another important issue relates to greater clarity in OIVD’s policies. This factor applies to a broad range of issues, such as when de novo will be available (to its credit, OIVD has been much more willing to use de novo than other offices at CDRH) and what data will be needed to support submissions.

“To some extent, FDA is reevaluating what it’s looking at in terms of its regulatory processes, such as what’s appropriate for de novo and what’s appropriate for 510(k),” says Jonathan Kahan, JD, a partner at Hogan & Hartson LLP (Washington, DC). “My feeling is that FDA is upping the ante in the poker game right now. Because of the all the criticism of the 510(k) process, the agency is much more wary about calling something a 510(k). So I think the industry is going to see more PMAs, and Alberto is going to have to make some decisions as to how he’s going to continue. Steve Gutman was a proponent of utilizing the de novo process, but I don’t know where Alberto stands on that.”

In addition, OIVD has an entire new set of paradigms that it is considering for clinical trial data and IVDs. Some of the things that are of great concern to the IVD industry is the reinventing of the wheel regarding what OIVD wants in clinical data for new cancer and other novel diagnostic products, especially where there is not a good comparative product. Gutierrez has already weighed in on this issue to some extent by saying that he thinks OIVD has not been as strict as it could be as to what is required in terms of substantial equivalence and testing for 510(k) products. The whole question of clinical-data support and the level of data support, because they are needed for both 510(k)s and PMAs, is going to be important.

“There are more IVD companies reporting that they had submitted a pre-IDE application, received feedback from OIVD, and performed the agreed upon study, but then OIVD turns around and says the data are insufficient,” says Jeffrey N. Gibbs, JD, a director at Hyman, Phelps & McNamara (Washington, DC). “Those events not only make it difficult for the applicant, but also reduce confidence in the utility of discussions with OIVD. While the agency does need the flexibility to modify agreed upon requirements when necessary, it should not do so lightly and should explain its reasons for these kinds of changes.