News, Policy & Media

25Aug

FDA streamlines approvals process for COVID-19 tests

The U.S Department of Health and Human Services has issued a decision stating that the Federal Drug Association (FDA) will no longer require a premarket review of lab-developed tests during the COVID-19 pandemic. This move means that requirements are based on notice-and-comment rulemaking versus guidance documents, compliance manuals, website statements or other informal issuances. The decision comes in the midst of an apparent rift between HHS Secretary Alex Azar and FDA Commissioner Stephen Hahn and it appears to have surprised FDA insiders also. Hahn has insisted that the FDA should have the authority to regulate laboratory-based diagnostics during a public health emergency, such as the COVID-19 pandemic.

Medtech experts have said they recognise the desire to reduce barriers to market entry during the pandemic, however they are concerned about the inability of the FDA to flag sub-par diagnostics going forward. “It also removes the post-market oversight that is required for devices cleared or approved by the FDA. That oversight is critical in these times to ensure that providers are using the best tests available”, said a former FDA manager. American President Donald Trump has been increasingly critical of the FDA, accusing them of holding off on approving treatments and diagnostics for COVID-19 for political purposes. This week however, the FDA made a step forward in terms of widening treatment options for COVID-19 by approving the use of convalescent antibody plasma for fighting COVID-19 in virus-positive patients. AdvaMed CEO Scott Whitaker in a statement called on the administration to support the creation of a single regulatory framework for both in vitro diagnostics developed and made by the trade group’s members, and laboratory-developed tests (LDTs).

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