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."

Jump to Page

Privacy Preference Center

When you visit any website, it may store or retrieve information on your browser, mostly in the form of cookies. This information might be about you, your preferences or your device and is mostly used to make the site work as you expect it to. The information does not usually directly identify you, but it can give you a more personalized web experience. Because we respect your right to privacy, you can choose not to allow some types of cookies. Click on the different category headings to find out more and change our default settings. However, blocking some types of cookies may impact your experience of the site and the services we are able to offer.

Strictly Necessary Cookies

These cookies are necessary for the website to function and cannot be switched off in our systems. They are usually only set in response to actions made by you which amount to a request for services, such as setting your privacy preferences, logging in or filling in forms. You can set your browser to block or alert you about these cookies, but some parts of the site will not then work. These cookies do not store any personally identifiable information.

Performance Cookies

These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. They help us to know which pages are the most and least popular and see how visitors move around the site. All information these cookies collect is aggregated and therefore anonymous. If you do not allow these cookies we will not know when you have visited our site, and will not be able to monitor its performance.