Originally Posted by
Hancocks
Keep things in perspective. The FDA introducing regulation of LDT’s is a natural progression of a process that is now so complicated that the original intent is redundant.
Initially, LDTs were generally relatively simple, well-understood pathology tests that were intended to be used by physicians as part of patient care. But in recent years LDTs have become increasingly complex.
FDA approval, is it achievable for CxBladder? Easy peasy, no drama, no sweat, it shouldn’t cause any undue stress to Pacific Edge shareholders.
The U.S. Food and Drug Administration (FDA) examines, tests, and approves a wide range of items for medical use, including drugs and medical appliances. In the simplest terms, “FDA approval” means that the FDA has decided the benefits of the approved item outweigh the potential risks for the item’s planned use.
The FDA does not do its own testing of new drugs, medical devices, or other items. Instead, it reviews the results of clinical testing and studies performed by the item’s manufacturer.