Proactive steps taken premarket can ensure legal compliance and avoid unnecessary liability in the future.
The CDC (Centers for Disease Control) recommends that people wear masks in public settings, like on public and mass transportation, at events and gatherings, and anywhere they will be around other people. Masks may help prevent people who have COVID-19 from spreading the virus to others and are most likely to reduce the spread of COVID-19 when they are widely used by people in public settings.
Along with this recommendation, many businesses, individuals, and other entities have stepped up to assist in manufacturing and distributing the additional masks needed to keep up with the increasing demand. Proactive steps taken premarket can ensure legal compliance and avoid unnecessary liability in the future.
Are Facemasks Regulated by the FDA?
Face masks used in hospital and surgical settings are considered medical devices and are therefore regulated by the FDA (Food and Drug Administration). Face masks, such as the type recommended by the CDC for the general public to help slow the spread of COVID-19, are also considered medical devices. Normally, non-surgical face masks worn by the general public in this type of scenario would be considered a Class I medical device and would require a plethora of strict regulations in order to be produced.
How Were Regulations Changed To Facilitate Public Need?
On April 18, 2020, FDA issued an Emergency Use Authorization (EUA), which authorized the use of face masks for use by the general public in connection with the COVID-19 pandemic allowing the production of facemasks for public use without jumping through the usual regulatory hoops as long as they meet the requirements of the EUA. This allows the face masks to get to those who need it much more quickly. Some of the changes include a shorter approval process for medical products, the use of unapproved medical products, and the use of unapproved medical products in an emergency.
That being said, the EUA requirements must be strictly followed to be legally marketed and avoid going through the previous FDA regulatory channels. Failure to do so could result in your product being illegally marketed or misbranded, which can result in the recall of the products, forfeiture, seizure of products and profits, criminal penalties, and/or hefty civil fines. In other words, it is not worth it to cut corners and get caught.
What Is the Public Readiness and Emergency Preparedness Act (PREP)?
In March, the Department of Health and Human Services issued a declaration that authorized the Public Readiness and Emergency Preparedness (PREP) Act. This act gives immunity to certain businesses that provide medical materials meant to help combat COVID-19. While the PREP Act offers immunity, it is vital to know it is not absolute. In fact, businesses must meet specific guidelines and conditions not to be responsible for certain types of liability claims.
Will the PREP Act Protect A Business from All Liability?
Whether a business has protection from the PREP Act depends on many factors. The PREP Act does not provide immunity:
- Against federal enforcement actions
- From every type of claim – in fact, the immunity is limited to personal injury or property damage claims.
- To products used before or after the emergency period, which runs from Feb. 4, 2020, to Oct. 1, 2024
- To claims of death or serious physical injury due to willful misconduct
- For foreign claims where the U.S. has no jurisdiction or where U.S. law does not apply
What are the Basic Standards that Mask Manufacturers Must Complete?
- The product is labeled accurately to describe the product as a face mask and includes a list of the body contacting materials (which does not include any drugs or biologics)
- The product is labeled accurately so that it does not claim to be intended for use as a surgical mask or to provide liquid barrier protection.
- The product labeling includes recommendations against use in a clinical setting where the infection risk level through inhalation exposure is high.
- The product is not labeled in such a manner that would misrepresent the product’s intended use; for example, the labeling must not state or imply that the product is intended for antimicrobial or antiviral protection or related uses or is for use such as infection prevention or reduction;
- The product is not labeled as a respiratory protective device, and therefore should not be used for particulate filtration.
- The product is not labeled for use in high-risk aerosol-generating procedures.
- Take steps to ensure that the labeling information is available to the end-user.
- Include instructions regarding the recommended cleaning of the materials.
- Implement a process to report adverse events.
- Maintain records related to the Emergency Use Authorization.
- Comply with certain requirements for advertising and promoting the masks.
How Can We Help You?
Whether you are a manufacturer or a consumer, we invite you to contact The Law Office of Kamensky, Cohen & Riechelson immediately to offer you the most efficient, knowledgeable, and fair solution. Your rights are important to us, and we are here to defend them. You can contact us at (609) 528-2596 or (215) 337-4915. We focus on success and get results, which is why we have been trusted by our clients for more than 40 years.