The Emergency Use Authorization (EUA), together with the Food and Drug Administration’s (FDA’s) guidance on COVID-19-related enforcement discretion, were put in place so medical product manufacturers, importers, and distributors can bring certain devices and OTC drugs to market more quickly to combat the COVID-19 pandemic. FDA is taking a risk-based approach as they help increase the availability of these medical products. However, this does not mean that the standards for these devices and drugs have lapsed. FDA continues to hold importers and manufacturers accountable to meet certain safety and effectiveness standards and accurately label their products.
What is the difference between an EUA and FDA’s enforcement discretion?
Enforcement discretion: FDA has issued a series of guidance documents to help provide wider access to certain products like face masks for the public and medical-grade devices for healthcare professionals. An early example was guidance around the production of hand sanitizer in mid-March. Due to the nature of the COVID-19 pandemic, these guidances will remain in effect until the public health emergency is over. It’s important to note that as long as the enforcement discretion guidance is followed, products identified under those guidances can be imported and distributed in the U.S. immediately, meaning they do not need advanced approval from FDA. Typically, these guidances use discretion for some FDA requirements, such as waving compliance with certain regulatory requirements such as 510(k)s, registration and listing, and quality system regulation requirements. Once the national emergency is over, FDA will return to their regular enforcement policies and these same products will need to meet all standard FDA legal requirements in order to continue to be imported and sold in the U.S.
EUA: FDA has the authority to issue EUAs, which allow “unapproved medical products or unapproved uses of approved medical products to be used in an emergency” when there are no “adequate, approved, and available alternatives.” Getting your product’s application approved for EUA use is a multi-step process. Manufacturers should first start “pre-EUA” activities and determine potential designations. Next, FDA requires a completed application that justifies your product falling under the EUA criteria. This submission must include specific safety, effectiveness, and risk-related data for the drugs and devices in question. Timelines for EUA submission reviews and determinations vary by product type and on a case-by-case basis, according to FDA. Once the EUA application has been reviewed and FDA has granted the EUA, FDA will add the manufacturer to the authorized list. Other criteria for EUAs to be issued include evidence of safety, effectiveness, and a risk-benefit analysis that determines that the “known and potential benefits of the product” outweigh the “known and potential risks.” This allows for some drugs and devices that have not yet been FDA-approved to be marketed in the US. Unless rescinded by FDA, the EUA for a product generally will remain in effect until the national emergency is over.
Who can be granted an EUA?
While there are many actors in a supply chain, it is important to note that manufacturers (or importers acting as an agent of the manufacturer in certain cases) are the ones responsible for applying for EUA acceptance. FDA has already granted many EUAs, you can find the full list here, and more will most likely be added as this pandemic continues.
U.S. Customs and Border Protection
Customs has put measures in place to help expedite shipments of pandemic relief products. They have asked for importers and their agents to provide advance notification of shipments of relief materials. Customs issued instructions for the import community regarding the filing of personal protective equipment and medical devices here.
Importation of products authorized under an EUA: When a medical device authorized under an EUA reaches the border, importers and their brokers should use the Intended Use Code 940.000: Compassionate Use/Emergency Use Device and the appropriate FDA product code. The Affirmations of Compliance for medical devices are optional in ACE under this Code.
Importation of products subject to Enforcement discretion: When a product subject to enforcement discretion reaches the border, importers and their brokers should use the Intended Use Code 081.006: Enforcement discretion per final guidance, and the appropriate FDA product code. The Affirmations of Compliance for medical devices are optional in ACE under this Code.
Most importantly there are still standards to be met.
Although these measures have been put in place to move needed products quickly, drug and device companies need to be extra aware that the functionality of their products is just as important. Unfortunately, we are seeing more and more reports of fraudulent or counterfeit devices and drugs, including hand sanitizer with unapproved new drug ingredients. FDA wants to ensure that these vital products not only get to the market where they are needed but also meet requirements that ensure safe and effective usage.
FDA has issued over 60 warning letters to companies selling products that claim to “prevent, treat, mitigate, diagnose or cure coronavirus disease 2019.” We recently saw significant changes in FDA’s approach to serology test kits and certain non-NIOSH approved disposable filtering facepiece respirators. Similarly, FDA is actively monitoring products subject to enforcement discretion to ensure they meet safety standards and do not make false or misleading claims. Ben England stressed this point by saying, “With enforcement discretion, FDA still wants the products to meet their appropriate standards — you do not ‘get a pass’ if someone gets a bloodborne infectious disease using your gloves. You will be sued.”
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This blog is provided for informational and educational purposes only and does not constitute legal advice, and is not intended to form an attorney-client relationship. Please contact your regular FDAImports representative for additional information.
