With the COVID-19 health emergency due to end on May 11, medical technology businesses that brought equipment to the marketplace under special rules for the pandemic will need to establish transition plans quickly, based on the most recent final guidance provided on March 24 by the Food and Drug Administration (FDA).
The FDA defined the measures that MedTech companies must take if their product has an emergency use authorization or was launched under a pandemic exemption.
For equipment with an EUA
The FDA stated that device EUAs will not expire immediately when the public health emergency subsides. Rather, the Secretary of Health and Human Services will issue an early notice of when the agency’s EUA designation will expire.
Businesses that want to continue selling their product in the future must submit a commercial proposal to the FDA before the EUA expiration date, according to the regulator. As a component of this procedure, companies should include a Transition Implementation Plan that covers how they will deal with previously distributed devices in the event of a favourable or negative FDA ruling. The FDA stated that it will not object to the ongoing distribution of products that are still under evaluation after their EUA expires, as long as their marketing filing has been approved by the agency.
Businesses that do not submit a submission to the agency must stop selling or testing their product by the EUA date of termination.
For devices supplied under another pandemic-related guidance
Since the time the pandemic began, the FDA has published numerous so-called enforcement discretion notices to increase the availability of certain types of devices.
For example, the FDA has stated that it will allow remote digital pathology equipment and digital health therapies for mental health disorders to be disseminated without prior approval. It will also allow adjustments to some types of devices, including diagnostic machines, ventilators, heart as well as lung machines known as ECMOs, and cardiopulmonary bypass devices, before even obtaining regulatory approval. Such exemptions will end after the pandemic designation expires, though the FDA has recommended a 180-day transition plan to give device manufacturers time to adjust.
On May 11, when all the public health emergency end, the transition period will begin. The FDA recommends device manufacturers begin preparing marketing proposals if they intend to continue selling their products. In the second phase, which begins after the 90 days of transition, the FDA said that firms should submit their proposal for clearance. For numerous kinds of life-support systems, such as oxygen machines and ventilators, the FDA needs manufacturers to let the agency know whether or not they intend to continue supplying the product in the future.
While the FDA’s pandemic guidelines will expire on November 7, the agency has stated that devices can continue to be disseminated provided their marketing proposal is accepted by the authority before then. In comments submitted in response to a draft version of the guidance released in December, medical device businesses and industry groups broadly supported the transition time, though several requested clarifications on some issues related to labelling and the supply chain procedure.
Abbott Laboratories stated that the suggested 180-day transition period is fair for device manufacturers to request and gain approval for the pre-market proposal.
AdvaMed, a medical device trade association, also supported the transition time but wanted additional flexibility with labelling modifications, such as allowing manufacturers to offer the information online and allowing customers to request updated labelling.
Cardinal Health, a manufacturer of gloves, gowns, durable medical equipment, and other supplies, pointed out that the FDA must allow for an appropriate timeframe that takes into account all downstream trade partners to avoid abrupt changes in product accessibility.
For example, clinicians may require more time to develop alternative products or treatment strategies, and distributors may require more time to develop other sources or items, depending on the business.
Allowing consumption until the expiration date will give EUA products enough time to navigate their way through the supply chain once the transition period begins.