Testing times
Christian Dickey, Biomedical Engineer at Ken Block Consulting, discusses the advantages of fast action in PPE compliance.
The COVID-19 public health emergency created a worldwide shortage of personal protective equipment (PPE). The FDA responded to this shortage through issuing multiple Enforcement Policy documents and Emergency Use Authorization (EUA) documents for PPE – including respirators, face masks, face shields, gowns, and gloves.
These temporary FDA policies allow for the marketing and distribution of certain medical devices without meeting the full “standard” FDA regulatory requirements. Although many of the same products are eligible under both the Enforcement Policies and the EUAs, there are different regulatory requirements applicable when following an applicable Enforcement Policy vs. following the applicable EUA. In addition to different requirements, EUAs are only issued and enforced during a declaration of emergency by the U.S. Department of Health and Human Services (HHS), whereas Enforcement Policies can be issued at any time and are not dependent on a declaration of emergency. The key differences, discussed below, may impact a manufacturer’s distribution timeline and marketability of their product(s).
Right policies – right time
Face masks, surgical masks, face shields, respirators, gowns, other surgical apparel (including surgical suits, caps, shoe covers, etc.), and gloves are included in the FDA’s current COVID-19 Enforcement Policies. These medical device specific policies include the “Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised)” published by the FDA in May 2020 and the “Enforcement Policy for Gowns, Other Apparel, and Gloves During the Coronavirus Disease (COVID-19) Public Health Emergency” published by the FDA in March 2020. These policies have established requirements for manufacturers, importers, and distributors to allow for the distribution of PPE without compliance to the following regulatory requirements: Premarket Notification, Registration and Listing, Quality System Regulation, Reports of Corrections and Removals, and Unique Device Identification.
The FDA has also released product-specific EUAs for many of these same categories of PPE. Similar to the Enforcement Policies, these product-specific EUAs identify the reduced requirements for distribution of each product category, during the COVID-19 public health emergency.
The EUA and Enforcement Policy requirements differ based on the type of PPE, which is dependent on design, intended use, and labeling claims. For instance, the most heavily regulated PPE category under the EUAs are surgical masks. Some of these additional requirements include testing for fluid resistance, flammability, particulate filtration efficiency, air flow resistance, and biocompatibility. In addition to meeting the EUA standards established for this category, this type of PPE requires a formal EUA submission to be filed with the FDA. Therefore, labeling a mask as intended for surgical use can further complicate and delay distribution of these masks in the situation when the same product could instead be marketed and distributed as non-surgical medical masks.
On the other hand, PPE that falls into the FDA-defined category of face masks has the minimum requirements of all the EUA-regulated face mask/respirator products. Face masks, as defined by the FDA, are those products that cover both a user’s nose and mouth and are intended for use by the general public and healthcare providers in accordance with the CDC recommendations. These masks still can, but do not need to, meet fluid barrier or filtration efficiency levels. The product requirements for face masks include establishing a Medical Device Reporting (MDR) process (refer to 21 CFR Part 803) and inventory control process, conforming to labeling requirements as stated in the EUA, and maintaining all records associated with product distribution under the EUA. Once these requirements have been met, the manufacturer can begin distribution in the US market, without an FDA submission.
Appropriate testing
The above are just two examples of different PPE categories included in the most recently published EUAs. They highlight how labeling and intended use can cause disparities between the regulatory timeline of different product categories identified under the EUAs.
As mentioned previously, manufacturers can also choose to market applicable products under the current Enforcement Policies. Using the previous example of surgical masks, the FDA requires that manufacturers with a product in this category have an established MDR process and have conducted testing on the fluid resistance and flammability of the surgical mask. Unlike the EUA for surgical masks, the FDA does not require a submission prior to distribution. This example depicts how the current Enforcement Policy requirements are less strict than those under the current EUA for surgical masks. Despite Enforcement Policies typically requiring less performance testing of products, there are very specific labeling requirements that must be adhered to. Even so, products can often be distributed more quickly under an Enforcement Policy due to the more limited FDA regulatory requirements.
Although the Enforcement Policy may allow you to market your product faster, marketing a product under an EUA can be beneficial for the device’s marketability. EUAs require more performance testing and procedural documentation, but surgical masks and respirators that are authorized via an EUA are published for customers to see on the FDA website, which may provide more market visibility for the product. Depending on each manufacturer’s current Quality System and existing performance testing of their product(s), the Enforcement Policy or the EUA may be the more strategic route of selling the product in the U.S. market during COVID-19.
Deciphering these new regulatory policies can be challenging, and deciding which policy will help your company reach its desired outcome can be even more difficult. In my role as a Biomedical Engineer at Ken Block Consulting, I have had the opportunity to work with various medical device companies to develop regulatory strategies that fit their bottom line. Most recently, I worked with a company that was attempting to enter the U.S. market using an EUA, but they struggled under the guidance of another regulatory specialist. Seeking regulatory guidance is important, but not all consultants are equal. Without the proper experience and knowledge of these new policies, a manufacturer risks wasting significant time and money. In addition to seeking the proper guidance, manufacturers are encouraged to review the FDA website for further information on specific EUA and Enforcement Policy requirements.
Finally, companies should plan for the long-term marketability of their products beyond the current pandemic. Specifically, many of the PPE products currently allowed through an applicable Enforcement Policy and/or EUA will require 510(k) clearance by the FDA once the pandemic is over (which will also require the company’s Quality System to be in compliance with all sections of 21 CFR 820). Working now to establish both the full FDA-compliant Quality System and create the necessary 510(k) submissions will allow continued distribution of PPE products beyond the pandemic period.