Devices

FDA Enforcement Discretion Policy for Pandemic Tests

FDA says it is developing a general policy for the use of enforcement discretion for unauthorized tests in public health emergencies, which will be based on “lessons learned” from both the Covid-19 and monkeypox public health emergencies. The agency acknowledged the effort during a recent Government Accountability Office (GAO) review of Covid-19 health and economic effects and the government’s response to the emergency.

A just-released GAO report recommended that FDA “develop a policy for the use of enforcement discretion regarding unauthorized tests in future public health emergencies. The policy should include the conditions under which FDA would begin and end the use of such discretion.” The agency concurred with the recommendation and as of April it had begun developing the policy, the report says.

The report says that at the beginning of the pandemic (3/2020), at which point there was a significant shortage of available tests, FDA granted emergency use authorizations for some Covid-19 tests and issued policies that enabled some tests to be used without first obtaining an authorization. “By 9/30/2021, FDA had exercised its enforcement discretion for 370 tests,” it says. “FDA officials told us they had concerns about the lack of review for these unauthorized tests, and as the number grew, the risks of this policy began to outweigh the benefits. Nevertheless, FDA did not update its Covid-19 test policy with the intention of phasing out the agency’s use of enforcement discretion and reducing the number of unauthorized tests until 11/2021.

“Until FDA develops a policy,” the report continues, “for the use of enforcement discretion regarding unauthorized tests in a future public health emergency — including the conditions under which FDA would begin and end such discretion — the agency could face the risk that unauthorized tests could be used for an extended period of time, even when a sufficient number of authorized tests are available. This could hamper an effective response and recovery during a future crisis.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome