FDA Draft Guidance document outlines a 180-day transition period and requirements for pursuing marketing authorizations post EUA.
Author: Luis Jimenez, Vice President, Business Development
The US Food and Drug Administration (FDA) CDRH issued draft guidance outlining its proposed transition for Medical Devices in December 2021, with industry comments due by March 23, 2022. The plan, which explains what will happen when the Emergency Use Authorization is ended, will inevitably impact manufacturers currently supplying products under the EUA, creating an urgent need to prepare for a post-EUA era.
The EUA Program has provided a conduit for temporary approval to market products in the U.S., helping to address the medical supply shortage during the COVID-19 pandemic. Similar programs were employed in other countries to ensure access to essential supplies. As the national emergency status is expected to deescalate in the foreseeable future, FDA has issued a guidance document outlining steps for manufacturers to continue or discontinue the supply of their products supplied under the EUA program in the U.S.
The EUA program allowed manufacturers to waive certain requirements to expedite the supply of much-needed medical supplies and diagnostics. Under the program, the FDA waived the following requirements:
- General controls
- Registration and listing
- Quality System Regulations
- Unique Device Identifier requirements
- 510(k) premarket submissions (during EUA only)
Of note is that the program did not confer exemption from the following requirements:
- Adverse event reporting
- Enforcement against claims of “FDA Approved”
The end to the EUA program will force a number of companies to decide whether to pursue a transition to standard marketing authorizations or discontinue their product.
The FDA states that it expects to provide 180 days (6 months) after the end of the state of emergency for manufacturers to complete the applications.
With the end of the program flagged, there are some important considerations and requirements when deciding on next steps. These include:
Expected Timeline: No definitive timeline for ending the emergency state has been established. However, FDA has flagged that the declaration of termination of EUA will come 180 days (roughly 6 months) before the end of the EUA period.
Notification of Intent and EUA Report (section V.A): A letter of notification of intent to supply is requested/required as soon as possible after guidance is finalized indicating the manufacturer’s intent to apply for marketing submission or discontinue distribution of product after EUA termination. If not supplied before the publication of advance noticed of EUA termination, this letter will be required no later than 90 days of that publication.
Marketing Submission: This refers to the appropriate registration submission which is expected to be submitted before the EUA termination date. Continued distribution of medical devices can be reasonably expected during the review process if FDA does not raise specific concerns relating to the continued supply. However, FDA expects manufacturers to comply with all applicable requirements during the review process to continue supply of products.
Transition Implementation Plan: This should be included in marketing submissions that outline plans for already distributed products in case of a positive decision and in case of a negative decision on the marketing submission.
Compliance to applicable requirements: Manufacturers are expected to fulfill their requirements through the transition program regardless of whether the FDA has issued a final notice regarding the application.
Already distributed product: Such products may, in general, continue to be supplied unless the FDA has issued an action to say otherwise. Manufacturers are expected to communicate clearly with patients and users on the status of their products. No further production of EUA designated products will be allowed past the EUA termination date without a proper marketing application lodged with the FDA following a proper transition plan.
The drafting of this notice should provide manufacturers the opportunity to carefully consider their next steps. Those wishing to continue to supply their products to the market should focus on the following:
- Evaluation of market potential versus regulatory hurdles to obtain registrations
- Options and possibility of gathering real-world evidence (RWE) data to document the product’s clinical performance and supplement any clinical evidence gaps
- Consolidate key elements of general controls, including proper design control files with design history file, verification and validation and design master file
- Upgrades to quality systems as applicable.
At PharmaLex we have the experience to navigate regulatory changes and transitions and to help companies update their quality systems and prepare technical file documentation to ensure that the transition to market authorizations goes smoothly. Please reach out if you are evaluating your options and need support. Scenarios and further reading:
The draft guidance provided useful examples of scenarios and the potential outcomes. These are summarized below:
|Type of Product and Desired Outcome||Result|
|Manufacturer of surgical masks issued UEA
No longer desiring to continue supply
|Continuous ventilator and accessories issued through the EUA
Not desiring to transition to FDA registration
|Original equipment manufacturer (OEM) worked with medical device manufacturer to manufacturer ventilators marketed under umbrella EUA and distributed by OEM
Desires to transition to premarket review activities
|Molecular COVID-19 IVD received EUA for nasal swab and pooled samples
Desires to transition to a marketing submission
Source Draft Guidance: https://www.fda.gov/media/155039/download