Stakeholders request more time to transition EUA devices, diagnostics

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Posted on March 25, 2022 | By Ferdous Al-Faruque

In response to two U.S. Food and Drug Administration (FDA) draft guidance on transitioning products granted emergency use authorization (EUA) during the pandemic to regular market authorizations , key stakeholders have raised concerns that the agency is not giving enough time to collect the necessary data or make labeling changes after the current public health emergency (PHE) ends.

In December, the FDA released two highly anticipated draft guidelines titled “Transition plan for medical devices that fall under enforcement policies issued during the public health emergency related to coronavirus disease 2019 (COVID-19),” and “Transition plan for medical devices issued emergency use authorizations (EUAs) during the public health emergency related to coronavirus disease 2019 (COVID-19).“If finalized, the guidelines state that products currently marketed with EUAs should submit premarket applications and change their product labeling within 180 days of the end of the PHE. (RELATED: FDA proposes 180-day transition before ending COVID-19 EUAs and enforcement policies, Regulatory guidance January 4, 2022)

Several stakeholders noted that manufacturers do not have enough time to comply.

limbixdeveloper of a mental health app to treat depression, said the FDA’s proposal may seem sufficient at first glance, but 180 days isn’t enough for manufacturers to collect the clinical data needed to keep their product on the market.

“We are concerned that due to the challenges of conducting well-controlled clinical trials in the pediatric population and the time between submission and acceptance, as well as the number of potential submissions that will require FDA review during this period, 180 days may not be adequate,” the company said. “We are asking the FDA to extend this timeline to a minimum of 12 months or allow case-by-case consideration of an extension for manufacturers who are working in good faith toward FDA clearance, such as indicated having completed a pre-submission meeting with the FDA and/or are in the middle of a clinical trial to demonstrate the safety and efficacy of the device.

“This will allow manufacturers to continue to meet the needs of providers and patients who have thus far benefited from their devices without disruption as they strive to obtain FDA clearance during these difficult times,” Limbix added.

Medtech Industrial Group AdvaMed focused on the FDA’s requirement that EUA manufacturers remove their product from shelves or update their labeling to indicate that the product is under regulatory review and not yet FDA approved. The group says the agency has grossly underestimated the time and effort required to update product labeling and instead proposes that manufacturers be allowed to update their labeling electronically so consumers get Additional Information.

“Based on previous years’ manufacturer experience with labeling updates, the total average load associated with labeling mitigation for reusable devices will be 30 hours (for electronic labeling) or 60 hours (for physical labeling) as opposed to 1.25 hours cited in the proposed FR advisory,” AdvaMed said. “Please note that these are conservative estimates and the time may be up to 4x longer depending on device and context, with charging much more expensive than the time charging projections provided by the FDA.”

Industry groups said they don’t believe the FDA considered the labor demand to update labeling, including internal review processes and logistical needs to distribute the labeling.

AdvaMed added that the FDA’s proposal to require labeling changes twice, once during FDA’s review of an EUA trying to obtain regular market authorization, and then after having received a decision, is “excessively onerous”. users on the status of the products.

Allowing manufacturers to simply post updates to their EUA label on their website rather than physically on their products, AdvaMed said, would significantly reduce the burden on businesses while increasing timely and accurate product information for consumers.

“We propose for ‘publicly available labeling’ that the FDA allow alternative electronic mechanisms for notification of updated labeling, including providing a mechanism on a manufacturer’s website for customers request the updated labeling,” the group said. “We also propose that the recommendation of a physical copy of labeling for reusable life support and life support devices can be adequately met when a manufacturer provides electronic labeling to its customers and offers customers the possibility of requesting physical labelling. Additionally, to alleviate customer confusion regarding device status, we recommend that the Agency remove the proposed requirement for EUA devices with subsequent marketing submissions that are pending review to update. labeling to indicate that the device remains under FDA review for clearance or approval.”

the American Association of Clinical Laboratories (ACLA) also wrote to clarify that their members’ products will not be regulated under the FDA’s proposed guidelines. While the agency has long sought to regulate lab-developed tests (LDTs), the agency has used its enforcement discretion to refrain from doing so. Past efforts to develop guidelines for using a risk-based approach to regulate LDTs ​​have also failed after encountering political obstacles, though lawmakers are working on legislation to give the FDA explicit authority to oversee the sector.

In its commentary, CAWA notes that since LDTs ​​are not considered devices distributed by laboratories, the provisions of the guidelines do not apply to their members.

“ACLA interprets the FDA’s silence on this issue as an acknowledgment by the agency that once the EUA statement is complete, the regulatory posture for such testing will return to standard,” the group said. “That is, such tests will be subject to the discretion of the application like other LDTs.”

“However, notwithstanding ACLA’s understanding, we request that the FDA clarify in the final guidance that after the termination of the diagnostics-relevant EUA statement, COVID-19 LDTs ​​will be subject to FDA general policy. in discretionary application for LDTs,” he added. “This would mean that labs that currently offer COVID-19 LDTs ​​in accordance with EUAs do not need to submit an additional ‘marketing submission’ to the FDA to continue offering such tests after the EUA declaration is complete. Additionally, high-complexity labs that develop COVID-19 LDTs ​​in accordance with appropriate CLIA requirements after EUA reporting ends do not need to seek marketing authorization from the FDA to offer such tests. .

© 2022 Society of Regulatory Affairs Professionals.


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