Medical diagnostic tests — like a test for blood sugar levels — used to diagnose and treat illnesses such as diabetes are key to effective treatment. Many companies are developing tests but not getting them approved by the Food and Drug Administration because the process is unclear and unnecessarily expensive.
If a new diagnostic test is truly novel then the FDA labels it “class III,” meaning it must be evaluated like a high-risk device, such as an artificial heart valve is: over many years and costing millions of dollars, despite the fact that it may be a simple blood test. Smaller companies often can’t afford this, so they market their tests elsewhere, like Europe, where the approval process is more reasonable.
Senators John McCain, R-AZ, and Robert Casey, D-PA, proposed the SET Device Act, now under consideration in Washington, which will streamline this process for medical devices. A simple amendment to the SET Device Act will ensure that a study is done to evaluate the current process and ensure that the new process will still protect consumer safety. American patients will benefit greatly from new and better diagnostic tests. We need them to be safe, accurate, and available. We should demand that congress makes these changes.