AMP submits written comments to FDA on proposed regulation of laboratory developed tests

The Association for Molecular Pathology (AMP), a global, non-profit organization serving molecular laboratory professionals, recently announced that it has submitted written comments to the U.S. Food and Drug Administration (FDA) in response to its request for feedback on the proposed draft guidance titled, “Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories; Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs).”

During a public workshop hosted by the FDA on January 8-9, 2015, representatives from AMP’s leadership joined nearly 75 other stakeholders who provided feedback on the FDA draft guidance. AMP voiced numerous concerns with the draft framework, including what AMP characterized as its interference with the practice of medicine and its potential impact on patient access to vital molecular testing services that they and their laboratories offer.

AMP reaffirms these concerns in their written comments, expressing that medical device regulations are poorly suited for, and inapplicable to, the oversight of LDTs, which AMP refers to as Laboratory Developed Procedures (LDPs) to emphasize that they are medical services. If the guidance is finalized as written, FDA would require laboratories, as medical device manufacturers, to submit applications for premarket review for thousands of laboratory developed testing services. AMP members will likely be unable to continue offering these tests; therefore, FDA will have in effect significantly diminished or eliminated patient and physician access to these services. Additionally, FDA’s proposal would not permit molecular pathology professionals the current flexibility to make improvements to already approved or cleared tests, such as analyzing specimens from minimally invasive procedures, essentially freezing outdated tests in time.