Megan Robertson Quoted in “FDA Wrapped: Prominent Guidance from 2024”

Megan Robertson, Senior Counsel in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in MD+DI, in “FDA Wrapped: Prominent Guidance from 2024,” by Heather Johnson.

Following is an excerpt:

The FDA Center for Devices and Radiological Health (CDRH) maintained a brisk pace after a record-breaking 2023. Among other activities — most notably, granting marketing authorization to novel devices — the agency kept the industry informed by way of dozens of guidance documents on everything from artificial intelligence to dental devices. …

Up in the air: Laboratory-developed test rule

In May, CDRH issued a final rule stating that in-vitro diagnostics are considered medical devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act), even when the manufacturer is a lab. The FDA will phase out its less-restrictive enforcement policy over the next four years. The first milestone takes place May 6, 2025. At that time, certain IVD developers will have to comply to medical device reporting requirements, correction and removal reporting requirements, and quality system requirements. …

“The final rule certainly caused a lot of discussion among industry, particularly among small and mid-sized labs,” said Megan Robertson, senior counsel for Epstein Becker Green, who focuses her practice on the clinical laboratory and medical device industries. “Labs of all sizes and specialties have been watching and waiting to see what happens, both from the two lawsuits, as well as letters from American Society for Clinical Pathology (ASCP) and College of American Pathologists requesting the incoming Trump administration rescind the rule.” …

“We’re looking at 2025 as possibly an improving environment for device innovation,” Robertson told MD+DI. “There could be an opportunity for the administration under president-elect Trump to roll back some of the more controversial FDA actions and allow for more flexibility.”