FDA eases labeling, clarifies IVD requirements in COVID transition guidances

The US Food and Drug Administration (FDA) has made several changes to its guidances for transitioning medical devices and diagnostics from COVID-related authorization to traditionally marketed products – but it hasn’t budged on the 180-day transition timeline.

On 24 March, the FDA Center for Devices and Radiological Health (CDRH) published two final guidances for transitioning medical devices and diagnostics that have been temporarily allowed on the market due to the COVID-19 pandemic public health emergency (PHE). The Biden administration has said it does not plan to renew the PHE after 11 May, which means many products currently on the market will need to transition to traditional pathways.

“Given the magnitude of the response to the COVID-19 pandemic, CDRH is taking steps to assist stakeholders, including industry, health care professionals, and patients, who may need time to transition from certain temporary emergency measures,” said CDRH Director Jeff Shuren. “CDRH developed these transition guidances to help avoid disruption in device supply and facilitate compliance with applicable requirements while providing stakeholders with recommendations and an appropriate transition period to ensure an orderly and transparent transition to normal operations.”

Early last year, FDA published two draft guidances, one for products with emergency use authorization (EUA) and another for those under its enforcement policies, that laid out its plans for transitioning products granted marketing under the PHE. While the agency has made several updates to the final guidances, a big ask from health app company Limbix for up to a year to transition to traditional marketing was not included (RELATED: Stakeholders ask for more time to transition EUA devices, diagnostics, Regulatory Focus, 25 March 2022).

“We recognize that it will take time for device manufacturers, device distributors, health care facilities, health care providers, patients, consumers, and the FDA to adjust from certain policies adopted and operations implemented during the COVID-19 pandemic to normal operations,” said the agency. “Importantly, as outlined in the final transition guidances, there will be a 180-day transition period for these devices to help avoid disruption in device supply and help ensure an orderly and transparent transition.”

FDA seems to have taken into consideration some of the concerns raised by AdvaMed about labeling requirements being too burdensome during the transition period in the EUA draft guidance. Originally, the agency said manufacturers would either need to remove their product from the market or update the labeling to let users know that their product was transitioning.

AdvaMed argued that FDA had greatly underestimated the amount of time and effort it takes to update product labeling and proposed that manufacturers be allowed to update their labeling electronically for consumers to get additional information, substantially reducing the burden on companies while increasing timely and accurate information for consumers.

FDA removed the interim labeling requirements in its EUA transition guidance. Instead, the agency says it expects manufacturers to comply with all applicable requirements including any labeling updates, after its decision on the marketing submission for a device.

In the guidances, FDA has also provided additional details on its labeling requirements including labeling for products where the manufacturers does not plan on keeping their product on the market after the PHE is over.

In response to the draft guidance, the American Clinical Laboratory Association (ACLA) asked FDA to clarify that their member products were not going to be regulated. While the agency has long sought to regulate laboratory developed tests (LDTs), the agency has used its enforcement discretion to refrain from doing so.

In the final EUA transition guidance, FDA clarifies the matter. It notes that in vitro diagnostics (IVDs) authorized under an EUA are generally authorized for use in specific settings, such as those certified as laboratories under the Clinical Laboratory Improvement Amendments (CLIA), that meet the requirements to perform high or moderate complexity tests, or for use at the point-of-care (POC).

“FDA’s determination that an EUA-authorized IVD is deemed to be in a particular category of
examinations and procedures under CLIA is effective only while the relevant declaration…is in effect,” said the agency. “Outside of EUAs, CLIA categorization typically is determined by FDA after FDA has cleared or approved a marketing submission.”

Once an IVD is no longer under an EUA, FDA will take steps to categorize the product depending on its level of complexity. In particular, IVDs authorized for use in patient care settings under a CLIA waiver will be reviewed by FDA under its dual 510(k) and CLIA Waiver or de novo and CLIA Waiver pathways.

“FDA anticipates that, in many cases, manufacturers will be able to reference data from related marketing authorizations and submissions, including the EUA request, and real-world data obtained as a result of use of the IVD under the EUA may be submitted in support of a CLIA Waiver by Application,” said FDA, which recommends IVD manufacturers looking at the dual application pathways to use the agency’s presubmission process to discuss their products with regulators early on.

EUA Guidance
Enforcement Policy Guidance

FDA eases labeling, clarifies IVD requirements in COVID transition guidances

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