The U.S. Food and Drug Administration (FDA) published two final guidelines on March 24, 2023, to help manufacturers of medical devices transition away from specific procedures and policies put in place during the COVID-19 Public Health Emergency (PHE). The guidelines give a general overview of the systems the FDA suggests businesses take to move their devices from PHE-era policies and operations into “normal operations” when the PHE expires.
The FDA advises businesses to familiarize themselves with the guidelines and create a transition plan that details the actions they must take to continue marketing their devices in the United States.
EUA medical device enforcement policies
Due to increased demand and limited supply for some devices, the FDA realized the medical device supply chain needed to be extended at the start of the PHE.
The FDA issued enforcement regulations and Emergency Use Authorizations (EUAs) to increase the accessibility of devices “intended to support the emergency response to the COVID-19 pandemic” since these devices were intended to diagnose, treat, and prevent COVID-19 and related disorders.
Examples of acceptable medical devices are:
- Molecular diagnostics
- Personal safety gear meant for use in medicine
The FDA is working to ensure a smooth transition from the PHE toward standard standards for these devices. The organization published two guidelines that suggest transition strategies for devices that: fall under specific enforcement guidelines set under a EUA during the PHE.
Companies selling gadgets in one or both categories must give themselves enough time to prepare those devices for routine use. Many businesses must go through a drawn-out marketing submission process for their products.
The FDA advises businesses to start immediately by creating a pre-submission during the changeover phase to avoid delays in the marketing submission procedure. Companies meet with FDA during a pre-submission to clarify any uncertainties regarding the FDA’s examination of their device.
FDA then provides feedback, which businesses can use to improve their marketing submissions and, hopefully, speed up the review process.
FDA’s phases for EUA Devices
Phases of the transition are not used for EUA devices by the FDA, which “instead relies on the advance notice(s) of termination process required under Section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act).”
FDA is soliciting a Notification of Intent from makers of specific reusable life-supporting or life-sustaining equipment for which a EUA has been granted in the guidance for EUA medical devices. This notification lets the FDA know if the manufacturer plans to submit a marketing application after the EUA expires.
Suppose a device still carries labeling previously approved under the EUA. In that case, FDA does not intend to raise concerns about the lack of a Unique Device Identification (UDI) or other labeling requirements. In contrast, the device is still being reviewed.
What is the FDA’s 3-phase transition process?
Phase 1: Commences on May 11, 2023, the implementation date.
Manufacturers start Phase 3 preparation by following the 21 CFR Part 803 standards for adverse event reporting.
Phase 2: It starts on August 9, 2023, 90 days following the implementation date. The requirements for registration and listing (21 CFR Part 807 Subparts B-D) and reporting of corrections and removals (21 CFR Part 806) are followed by manufacturers. Only businesses distributing their devices after Phase 2 must comply with the registration and listing requirements.
Phase 3: starts on November 7, 2023, 180 days following the implementation date. There will be changes to some guidelines. Companies that have submitted a product’s mandatory marketing submission may continue distributing the device if the FDA accepts the request before Phase 3.
The FDA does not intend to object to devices that don’t follow specific labeling and Unique Device Identification (UDI) criteria. At the same time, they are still being reviewed by the agency. These gadgets must, however, abide by additional rules, such as listing and registration.
How do I prepare for the EUA or PHE enforcement policies?
It could take many months to alter procedures so that devices can continue to be distributed in the United States because many manufacturers are already selling products that do not adhere to the FDA’s essential requirements for medical devices.
Now is the time to prepare if your medical product requires a marketing submission. If you wait too long, the marketing submission procedure can be delayed, and your device might lose compliance and stop being marketable.
How Quality Smart Solutions can help
Our experts at Quality Smart Solutions are here to help and offer medical device-related regulatory advice and support on successfully securing your medical device license. We can help you by responding to potential information requests, keeping your license updated, and reviewing your device labels (510k Medical Device Registration, Facility Registration & FURLS, IVD Device Registration, and SaMD Classification.
Contact us today to learn more about how we can support your compliance needs during and after licensing! Please find our contact information: