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# FDA Not Considering Infection Disease Tests Properly: Groups
- URL: https://www.fdaweb.com/fda-not-considering-infection-disease-tests-properly-groups/
- Published: 2016-04-27T12:00:00.000Z
- Updated: 2026-09-14T20:58:03.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5135509

The Infectious Disease Society of America, the American Society for Microbiology, and the Pan American Society for Clinical Virology say they are concerned that infectious diseases laboratory developed tests (LDTs), which they say have little evidence of providing unreliable results that lead to harmful patient care decisions, are not being appropriately considered by FDA’s proposed LDT regulations. [Writing](http://cid.oxfordjournals.org/content/early/2016/04/26/cid.ciw260.abstract?ref=fdaweb.com) in *Clinical Infectious Diseases*, the groups say that many infectious diseases LDTs have “a long history of safe and effective use in patient care, and our societies firmly believe the risks posed by \[them\] are dwarfed by their advances and benefits to patient care.”

While the three societies say that they support the need to ensure that LDTs are safe and effective tools for patient management, they are concerned that the proposed regulations will create serious barriers that could impede patient access to existing high quality LDTs and also threaten the innovation needed to keep pace with constantly changing and emerging pathogens.

The report says that the societies offer recommendations including: 

- FDA should ensure that clinical validity can be established by many sources, including peer reviewed literature, clinical guidelines, bench studies, data registries, postmarket data, and clinical trials. FDA should examine data-sharing models such as ClinGen, where evidence of clinical validity can be “crowdsourced” from multiple laboratories.
- FDA should allow LDTs that are high-risk to be compared analytically to high-risk approved devices as predicates.
- FDA should hold an expert panel meeting to assess the evidence of risk for viral load testing of transplant-associated opportunistic viral infections.
- The societies propose a two-year phase-in cycle for the oversight exemption for unmet medical needs, rather than the one-year sought by FDA.
- FDA should delay oversight of LDTs until several (three or more) commercial tests are approved.
- FDA should closely assess its effectiveness and consider mechanisms on how it can further streamline the review and approval process during emerging disease outbreaks.
- FDA should expand the regulatory definition of rare diseases for the purpose of LDTs.
- FDA should modify the definition of healthcare system to include instances where local, but non-system, healthcare institutions interact to provide diagnostic testing and expertise.