Legislators ask CDRH to review its CDS assistance
In a letter to Dr. Michelle Tarver, recently selected director of the Center for Devices and Radiological Health, a department of the Food and Drug Administration, 7 members of Congress have actually asked the company to clarify assistance that followed 21st Century Cures Act exemptions for scientific choice assistance from policy as medical gadgets.
"FDA's assistance does not show its normal risk-based method or think about the substantial medical oversight under which these tools are set up," they stated Tuesday.
WHY IT MATTERS
Congress excused CDS from guideline as medical gadgets, supplied they satisfy particular requirements, however legislators, led by Dan Crenshaw, R-Texas, and Ann McLane Kuster, D-N.H., offer clear guidance.
"The FDA appears to note internally irregular examples of...