In the wake of the COVID-19 pandemic, the FDA has sought to expand the availability of needed personal protective equipment (PPE) for the general public and healthcare professionals. Recently, for example, FDA published two enforcement policies announcing the relaxation of certain premarket review requirements for: (1) face masks and specific respirators (including N95 respirators) and (2) surgical apparel, including gowns and hoods, and examination gloves for both patient examinations and surgeries. As an example of how swiftly regulatory authorities are moving to incorporate developments to date, the guidance for face masks and respirators superseded the prior version for those products issued just the week before, on March 25, 2020. These policies are of particular interest not just to traditional medical device manufacturers but those in other industries pivoting to help increase the supply of PPE.
Under the newly published policies, FDA will not enforce premarket notification (510(k)), registration and listing, quality system regulation (QSR) requirements or unique device identification requirements for medical face masks and surgical face masks if the masks contain appropriate warnings and meet other criteria to prevent undue risks to health. Similarly, FDA will not enforce certain regulatory requirements for various gowns, apparel, and gloves. These two enforcement policies have fomented a number of questions for stakeholders seeking to lawfully market PPE during COVID-19.
The FDA believes that masks, with or without a face shield, intended for a medical purpose, but NOT intended to provide liquid barrier protection, do not create an undue risk as long as they meet the following criteria:
Reprocessing of single-use medical devices generally requires submission of a 510(k). However, in order to encourage the conservation of PPE while ensuring safe reuse, the FDA has created an expedited evaluation procedure through its Emergency Use Authorization (EUA) process. Throughout the duration of the public health emergency, manufacturers seeking to decontaminate otherwise disposable face masks or FFRs are advised to contact the FDA and provide certain information to CDRH-COVID19-SurgicalMasks@fda.hhs.gov, if available, about the reprocessing procedures. In order to help facilitate pre-EUA discussions, the FDA recommends that manufacturers provide as much of the data enumerated in the seven categories of information listed on pages 9 and 10 of the guidance document, including a description of the disinfection/decontamination process and controls.
In short, during the course of this public health emergency, the FDA does not require premarket notification for these types of gowns and has waivers for other premarket approval requirements, so long as the gowns do not create an undue risk.
As background, gowns that claim moderate to high-level barrier protection, such as ANSI/AAMI PB 70 Level 3 or 4, are regulated by the FDA as “surgical gowns.” FDA considers surgical gowns to be a higher risk “device” than gowns that claim minimal or low levels of barrier protection. This is because these gowns are intended to be worn by operating room personnel during surgical procedures to protect both the patient and operating room personnel from transfer of microorganisms, bodily fluids, and particulate material in moderate- or high-risk situations. Therefore, these gowns have substantial importance in preventing impairment of human health. In fact, the FDA considers such gowns to be class II devices, and, as a result, they are typically subject to the FDA’s 510(k) requirements, as well as FDA’s general controls.
While typically these gowns would be subject to those regulatory requirements, under the new enforcement policy, for the duration of the COVID-19 public health emergency, the FDA stated that manufacturers and distributors of moderate to high-level barrier protection gowns do not need to:
This assumes that the surgical gowns do not create an undue risk in light of the public health emergency.
FDA currently believes surgical gowns do not create such an undue risk where:
To the extent you omit claims regarding antiviral, antimicrobial protection, or use for infection prevention or reduction uses, and the gowns qualify as “non-surgical,” no FDA premarket review is required. This assumes that the gowns do not pose an undue risk based on FDA’s “undue risk” factors for non-surgical and minimal-to-low barrier surgical apparel:
Yes. The new enforcement policy states that the FDA does not intend to enforce any of the standard premarket requirements you mentioned for these gloves provided that the product labeling does not create undue risk. FDA believes that such devices do not create an undue risk where, for example, the product includes labeling that:
In summary, it is important for medical device manufacturers and distributors to understand the FDA’s current enforcement policies on PPE products. For more information about current guidance, please contact your Foley relationship partner. For additional web-based resources available to assist you in monitoring the spread of the coronavirus on a global basis, you may wish to visit the CDC and the World Health Organization.
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