Oversight of Laboratory Developed Tests

Executive Summary

For several years, FDA officials have indicated they are reconsidering the current “enforcement discretion” exemption from medical device oversight for in-house developed laboratory tests.  ACLA has met with FDA on several occasions, presented to the Advisory Committees, provided written comments to the agencies and many other forums espousing an interagency approach to oversight with CMS as the lead agency and public transparency through a limited registry of tests that have raised public interest.  In July 2010, FDA held a public meeting to obtain input on its intent to regulate all LTD's.   ACLA was an invited participant in the public meeting, provided public comment and submitted supplemental comments to the docket.   A summary of those comments follows.

Background

All ACLA members produce and perform LDTs, and thus will be directly affected by change in the oversight of these tests. It is important to emphasize the breadth, scope and value of LDTs, to demonstrate the need to move the oversight of LDTs forward in a measured way that does not have unintended consequences for patient care. 

Independent and hospital based clinical laboratories, physician pathology practices, and university medical centers all develop and validate tests in their own laboratories for physician directed patient care.  Examples of low risk, well established LDTs range from Pap smears, manual blood cell counts, erythrocyte sedimentation rates, microbiology cultures and susceptibility tests, among many others - to the new advanced diagnostics that derive from the mapping of the human genome and help fulfill the promise of personalized medicine.  In addition to these services that are fully developed and validated within the clinical laboratory, when a FDA-cleared test is modified by the clinical laboratory to improve the test, it is considered to be a laboratory-developed test. 

Many tests developed in the laboratory have provided major healthcare breakthroughs, especially in cancer and infectious disease.   Tests developed by clinical laboratories have also played a critical role in the nation’s emergency preparedness by allowing for the timely identification of SARs, Avian Flu, West Nile Virus, H1N1 and LDTs will hopefully continue to be available to assist in the identification of new emerging pathogens.

 

These select examples illustrate the importance of assuring a continued rapid accessibility to the latest science and the need for test oversight that evolves in a flexible and balanced way.  There are many more examples of LDT’s in use that allow for rapid response to keep pace with our nations most costly and menacing chronic diseases and emerging public health threats. 

It is critically important, in our view, for stakeholders – and FDA - to work together to identify oversight gaps and to prioritize actions according to risk.  Consultation with all stakeholders is essential to this process, to provide a broad range of views on what steps are necessary to close the gaps and how best to do this, taking into account of the goal of least burdensome regulation that does not interfere with the practice of medicine and avoids disruptions to patient care. 

ACLA encourages FDA to approach this discussion with an open agenda and a commitment to flexibility and balance, since clinical laboratories are not “traditional” medical device manufacturers.  Applying a strict paradigm based upon the regulation of “traditional” medical devices and applied to all LDTs will have major consequences to clinical laboratories – whose businesses and facilities are set up for far different purposes and in far different ways than those of device manufacturers, even IVD manufacturers – and will place those laboratories in jeopardy of being unable to comply and, in many cases, unable to continue important work in the development of cutting-edge LDTs.  This will have the unintended effects of slowing the availability of important tests and negatively affecting patient care.

ACLA members are the experts on how clinical laboratories operate – including how tests are developed, validated and how quality is ensured.  We recognize the need to communicate that information more effectively to FDA.  We also recognize that we must understand better FDA’s regulation of medical devices.  We hope to continue a constructive two way communication with FDA toward this shared understanding.   ACLA pledges our active support and engagement to reach a timely and positive outcome.