FDA should ensure that policies and requirements are consistently applied, and that the scientific evidence and rationale for decisions are communicated effectively to diagnostic test manufacturers. Communication from FDA to diagnostic test manufacturers should be as clear and as comprehensive as possible at the outset of the submission process. This will help manufacturers better plan their resources and time. It will also assuage undue angst that the regulatory bar will change during the process. FDA should improve communication between government branches and agencies so that consistent requirements are developed and applied and demonstrations of clinical utility in one branch are recognized by the other branches. FDA should involve the expert opinion of medical professional associations regarding clinical utility.

The Association for Molecular Pathology recognizes the difficulties that regulatory agencies face in the context of the rapidly changing landscape of diagnostic devices and technology and appreciates the transparent process FDA is undertaking to improve the review process for medical devices. AMP believes that a consistent, clear, and flexible regulatory process will result in improved public access to additional higher quality innovative tests; and could conceivably lower healthcare costs.

"AMP stands ready to assist the FDA through our expertise, creative problem solving, and unique perspective," added Dr. Sobel. "We would like to offer our input and interaction with the member departments and agencies to assist in developing a more consistent, evidence-based, and transparent process for regulating diagnostic devices."

Source: Association for Molecular Pathology