Guideline IDSA, ASM and PASCV Concern Over FDA Draft Guidance
Nov. 19, 2018
IDSA, ASM and PASCV support the need to ensure that LDTs are safe and effective tools for the management of patients. However, we remain extremely concerned that the barriers created by the proposed regulations will impede patient access to high quality ID LDTs. The review requirements, designed for tests manufacturers, will create an impossible challenge, both in financial and administrative resources, for routine clinical laboratories; a laboratory would likely be unable to undertake a single moderate risk 510(k) submission, let alone navigate the high risk premarket approval (PMA) process. The resource burden would likely force many laboratories to discontinue developing innovative LDTs and either move toward exclusive use of commercial IVDs or send testing to outside reference laboratories. We present three examples where loss of local and timely LDT testing due to FDA oversight would negatively impact the care of patients with serious infections.