James A. Boiani, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in 360Dx, in “FDA Resumes Move to Regulate LDTs, Likely Setting Up Legal Battle with Lab Industry,” by Adam Bonislawski. (Read the full version – subscription required.)

Following is an excerpt:

The US Food and Drug Administration is moving to regulate laboratory-developed tests (LDTs), setting up a potential legal battle with the lab industry.

In remarks at the American Clinical Laboratory Association's annual meeting this month, Elizabeth Hillebrenner, associate director at the FDA's Center for Devices and Radiological Health, said the agency is advancing plans to regulate LDTs through the rulemaking process.

Hillebrenner declined to give a timeline for when the FDA might present its plans for LDT regulation but said that the agency has started work on the effort. The move marks a resumption of the FDA's decades-long endeavor to bring LDTs under its purview.

For more than 30 years, the agency has maintained that LDTs are medical devices that fall under its authority according to the Food, Drug, and Cosmetic Act (FDCA). It has by and large refrained from exerting this supposed authority, however, adopting what it has called a policy of enforcement discretion. Perhaps the closest the FDA has come to broad regulation of LDTs was in a pair of draft guidances it released in 2014 in which it said it would require registration of LDTs and premarket approval of certain higher risk LDTs. …

James Boiani, an IVD, drug, and medical device life sciences attorney at Epstein, Becker & Green in Washington, D.C., noted that the length of time required to regulate through rulemaking makes the process vulnerable to political swings such as changes in presidential administrations.

"If you're talking about the rulemaking process, that is going to be a multiyear program with a multiyear phase-in, and that is going to be subject to changes in [presidential] administrations and how they feel about laboratory-developed tests," he said. He cited as an example HHS's surprise announcement during the Trump administration that the FDA would not require premarket review of laboratory-developed tests without notice-and-comment rulemaking.

Perhaps anticipating these challenges, the FDA has maintained that its preference is for Congress to pass legislation like VALID giving it authority over LDTs.

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.