In a letter to Dr. Michelle Tarver, newly appointed director of the Center for Devices and Radiological Health, a division of the Food and Drug Administration, seven members of Congress have asked the agency to clarify guidance that followed 21st Century Cures Act exemptions for clinical decision support from regulation as medical devices.

"FDA’s guidance does not reflect its typical risk-based approach or consider the significant clinical oversight under which these tools are configured," they said Tuesday.

WHY IT MATTERS

Congress exempted CDS from regulation as medical devices, provided they meet certain criteria, but lawmakers, led by Dan Crenshaw, R-Texas, and Ann McLane Kuster, D-N.H., provide clear advice.

"The FDA seems to list internally inconsistent examples of where the exception would apply," they said in a letter shared with Healthcare IT News.

"For instance, the FDA’s guidance indicates that CDS tools cannot qualify for the exemption unless they provide multiple recommendations."

CDS tools often provide a single recommendation when users determine there is only one appropriate option based on clinical practice guidelines.

"This guidance would seem to make much of CDS used throughout the healthcare system ineligible for the exemption," the lawmakers said, adding that time-critical situations fail the requirement for clinician reviews of CDS recommendations.

THE LARGER TREND

The lawmakers noted that in May the House Committee on Energy and Commerce asked the previous CDRH director, Dr. Jeff Shuren, about specific CDS tools that recommend single courses of action, and said his responses created "additional uncertainty for medical technology developers and providers."

Committee members asked Shuren and other FDA division directors what challenges they were facing and why they were not meeting critical performance processes and hiring goals, at times grilling the agency leaders over critical medical device missteps. 

Shuren said that most medical devices aren't getting to patients due to numerous obstacles from concept to commercialization. 

"It is appropriately called the valley of death," he said.

Crenshaw and Angie Craig, D-Minn., wrote to Tarver in September while she served as acting CDRH director after Shuren's departure in July with questions regarding the agency's intentions expressed in the Laboratory Developed Tests Final Rule. That rule would phase out its LDT enforcement discretion policy over a four-year period. 

ON THE RECORD 

"Many healthcare organizations deploy hundreds of CDS tools, and providers need clarity to determine whether their tools constitute a medical device and whether they must go through the medical device clearance process accordingly," the lawmakers said in their letter to Tarver.

"We urge the FDA to revisit its guidance and provide clear advice aligned with the 21st Century Cures Act’s language."

Andrea Fox is senior editor of Healthcare IT News.
Email: afox@himss.org
Healthcare IT News is a HIMSS Media publication.