Why FDA should oversee laboratory developed tests

By: Peter Lurie, M.D., M.P.H. Today FDA is issuing a report that illustrates the real and potential harms to patients and to public health from certain laboratory developed tests (LDTs) – tests that are designed, manufactured and used in a single laboratory. When FDA first began regulating medical devices under the Medical Device Amendments in the 1970s, we chose not to enforce applicable regulatory requirements for LDTs because they were relatively simple tests generally confined to local labs, and often used for rare conditions. But times have changed. LDTs have increased in complexity and availability and are now frequently used to diagnose common, serious medical conditions, including cancer and heart disease, with potentially greater impact on patients. And yet, LDTs are still under a general policy of enforcement discretion. That means they have rarely undergone FDA review to determine whether they are accurate, reliable, and provide clinically meaningful results. It also means that FDA’s own adverse event reporting databases rarely capture problems associated with a faulty LDT. Nevertheless, the Agency was able to pull together 20 case studies based on information available in the public domain that show how lack of LDT oversight may be causing or is causing significant harm to patients. Some LDTs provide positive results even though the patient doesn’t have the disease. For example, a patient can receive a false positive result from a test that is supposed to de...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Blog FDA Source Type: news