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 asked the agency to clarify guidelines that followed the 21st Century Cures Act exemptions for clinical treatments. decision support through regulations such as medical devices.
“The FDA guidance does not reflect the typical risk-based approach and does not take into account the significant clinical oversight under which these devices are configured,” they said Tuesday.
WHY IT’S IMPORTANT
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-New Hampshire, are providing clear guidance.
“The FDA appears to be listing internally inconsistent examples of where the exception would apply,” they said in a letter they shared Healthcare IT news.
“For example, FDA guidelines indicate that CDS instruments cannot qualify for the
exemption unless they make multiple recommendations.”
CDS tools often provide a single recommendation when users determine that there is only one appropriate option based on clinical practice guidelines.
“This guidance appears to leave a large portion of CDS used in the healthcare system ineligible for the exemption,” the lawmakers said, adding that time-critical situations do not meet the requirement for CDS clinical assessments recommendations.
THE BIG TREND
The lawmakers noted that the House Committee on Energy and Commerce in May removed previous CDRH director Dr. Jeff Shuren, had asked about specific CDS tools that recommend separate courses of action, saying his answers “created additional uncertainty for medical technology developers and suppliers.” “
Committee members asked Shuren and other FDA division directors what challenges they faced and why they failed to meet critical performance processes and hiring targets, sometimes calling out agency leaders over critical missteps in the medical device field.
Shuren said most medical devices don’t reach patients due to numerous obstacles from concept to commercialization.
“It is aptly called the Valley of Death,” he said.
Crenshaw and Angie Craig, D-Minnesota, wrote Tarver in September while she was serving as acting CDRH director after Shuren’s departure in July with to ask regarding the agency’s intentions expressed in the Laboratory Developed Tests Final Rule. This rule would phase out the LDT enforcement discretion policy over four years.
ON THE RECORD
“Many healthcare organizations are deploying hundreds of CDS devices, and providers need clarity in determining whether their devices constitute a medical device and whether they must go through the medical device approval process accordingly,” the lawmakers said in their letter to Tarver.
“We urge the FDA to revise its guidance and provide clear guidance consistent with the language of the 21st Century Cures Act”
Andrea Fox is editor-in-chief of Healthcare IT News.
Email: afox@himss.org
Healthcare IT News is a HIMSS Media publication.