Bradley Thompson, a Member of the Firm in the Health Care and Life Sciences Practice in the Washington, DC office, was quoted in IVD Technology magazine on key challenges facing Alberto Gutierrez, the recently appointed director of the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD).
The OIVD, which is part of the U.S. Food and Drug Administration’s Center for Devices and Radiological Health, regulates all aspects of in-home and laboratory diagnostic tests (in vitro diagnostic devices, or IVDs).
According to the article, “Gutierrez Appointed New OIVD Director,” Gutierrez and OIVD have several pressing issues to address, including how to streamline the diagnostic review process.
“A big challenge is the accelerating regulatory creep at OIVD,” said Thompson. “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.”