New guidance from the FDA will permit greater production and distribution of personal protective equipment by non-healthcare companies. The policy could help alleviate a shortage of the essential equipment needed to respond to COVID-19.
Executive IQ Brief
- How Things Work Now: Personal protective equipment (PPE) is used by health care providers to ensure their own safety when providing care to critically ill or infectious patients. These include both moderate- and low-risk devices such as surgical gowns, shoe covers and gloves. Some of these products are subject to premarket notification requirements, while lower risk products can come to market without a regulatory review or clearance from the FDA.
- What’s New: In a new policy intended to respond to the novel coronavirus outbreak, the FDA is waiving quality system requirements for PPE products for the duration of the emergency. Additionally, the FDA will not enforce premarket notification submission requirements for the device types that would have otherwise been subject to review and market clearance. The FDA further states that, if no FDA-cleared or approved PPE products are available, it will not take action against individuals using and distributing “improvised” PPE.
- Impact: Although the FDA has recently been allowing reduced regulatory barriers for devices to respond to the outbreak of COVID-19, this policy is the first specifically reducing regulatory requirements for Class I, premarket notification exempt devices. These products typically don’t face a significant amount of regulatory oversight. The removal of the quality system regulations for these devices, as well as waiving the requirement for 510(k)s for higher-risk PPE devices, could make it harder to track adverse events associated with a lack of PPE or the use of “improvised” PPE during or after the outbreak.
- What’s Next: The policy is effective immediately and will remain in effect for the duration of the Public Health Emergency.
Medical devices are stratified into regulatory categories depending on their risk profiles and intended use. Products that are high-risk or intended to sustain human life are typically categorized as Class III, which requires the highest level of regulatory oversight. Class I devices are the lowest risk devices, requiring a comparatively low level of oversight. Although some Class I devices are subject to premarket notification requirements (known as 510k submissions) most are exempt from pre-market submission requirements altogether.
The FDA has taken a “least burdensome” approach for medical devices, requiring regulatory oversight commensurate with the level of risk the device poses to a patient or a provider. The amount of risk a product poses includes a consideration of its intended use.
For example, although surgical isolation gowns are a Class II device, non-surgical isolation gowns are a Class I device that are also exempt from 510(k) requirements. Although all surgical apparel was originally categorized as Class II devices, the agency issued new regulation in 2000 to reclassify apparel other than gowns and masks, such as scrubs, shoes, and shoe covers, into a Class I device and exempt them from 510(k) requirements. Gowns that only provide minimal or low barrier protection from liquids are also considered a Class I device, while those that provide moderate or high levels of such protection are a Class II device.
The ongoing COVID-19 pandemic has raised significant concerns from lawmakers and front-line health care providers about the availability of personal protective equipment, or PPE.
As the result of that shortage of PPE, the FDA has issued several guidance documents intended to increase the availability and use of certain device types that could help protect front-line healthcare workers, including face masks and respirators. The FDA has generally done this in two ways: through allowing the importation of non-US cleared or approved respirators for use in the US under an Emergency Use Authorization (EUA) and by allowing these products to be reprocessed so that they may be used additional times (respirators are generally single use disposable items).
However, face masks are not the only PPE in reported shortage. Other equipment, including gowns and gloves, are generally in low supply as well. As a result, non-medical companies like Jockey, Hanes and the hat company Fanatics have begun manufacturing and distributing gowns and masks.
However, a key question has remained: To what extent can manufacturers make new PPE without falling afoul of FDA regulations about the manufacture of medical equipment?
Those companies now have an answer. On March 30, the FDA issued new guidance allowing the broader distribution and use of non-respiratory PPE, including surgical apparel, gowns and several kinds of gloves.
The FDA’s guidance states that if FDA-cleared products are unavailable due to high demand and limited supply, “individuals, including healthcare professionals, might improvise [PPE].” The agency states that it will not enforce policies against individuals that use and distribute “improvised” PPE.
Although several of the products are already listed as Class I and exempt from pre-market notification requirements, the agency states that for the duration of the public health emergency, it will also exempt these products from additional requirements to facilitate access. The newly waived requirements include registration and listing requirements, quality system requirements, correction and removal reports, and Unique Device Identification (UDI) requirements.
For the Class II devices (i.e., surgical isolation gowns, patient gowns, surgical gowns/togas, and surgical hoods), the FDA will exempt these devices from both the existing applicable 510(k) requirements and the quality system requirement flexibilities granted to the Class I products. However, the FDA states that these products should still meet applicable standards for sterility and flammability, as well as liquid barrier protection levels.
The gloves covered under the scope of the guidance are Class I devices that have not been exempted from the 510(k) process, as they have been determined to be of “substantial importance in preventing impairment of human health” or present an unreasonable risk of illness or injury. These include both surgical gloves and patient exam gloves. As with the Class II devices in the previous section, the FDA will also waive the 510(k) requirements, registration and listing, quality system regulation requirements, and UDI requirements. However, only patient gloves will have correction and removal reporting requirements waived. These requirements will still be in place for surgical gloves. In addition, labelling must be clear on all gloves about their intended use, sterility, and an indication that the products have not been cleared or approved by the FDA.
The FDA’s new policy aligns with several other policies recently released by the FDA and intended to increase the supply and availability of medical products used to address COVID-19.
However, it is the first time since the onset of the outbreak in the US that the FDA has exempted any Class I products, which generally do not face significant regulatory burden, from their oversight requirements.
The lifting of the quality system requirements may help ramp up production of the Class I and II products from qualified manufacturers, but the policy may also allow new and potentially less-safe products to enter the market. The shortages of these products, which do not require regulatory submissions and are fairly easy to bring to market, indicate significant problems with the medical device supply chain in the US, and that regulators are looking to non-traditional manufacturers to make up the difference in production capacity.
Notably, health care providers are still protected by workplace safety requirements under the Occupational Safety and Health Administration (OSHA). While the FDA may allow for the use and distribution of “improvised” materials as PPE, it’s unclear if these products will align with OSHA requirements.
OSHA standards for PPE have only been updated regarding annual respirator fit-testing in response to the COVID-19 outbreak, which allows for certain flexibility in the fit-testing of single-use respirators. Employers, such as hospital systems, are still required to maintain a log of certain workplace-related injury and illness, which the guidance indicates does include infection with COVID-19 related to patient care.
As with other recent guidance documents responding to the outbreak, this policy will be in effect throughout the duration of the declared public health emergency.
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