The Department of Health and Human Services (HHS) has made the Food and Drug Administration’s (FDA) temporary exemption from the 510 (k) pre-market notification process permanent for seven Class I medical devices. is also considering extending this permanent exemption to 84 other Class II medical devices, subject to the approval of the Biden administration. On January 15, 2021, HHS released its “Notice Regarding Permanent Regulatory Relaxations During COVID-19 Related to Certain Medical Devices”(Federal Register Doc. # 2021-00787). In the advisory, the HHS identified seven Class I devices (all medical gloves) as exempt from 510 (k) pre-market notification requirements. Newly exempt gloves include:
|Description of the device||Device class||Product code||Section in 21 CFR|
|Powder-free polychloroprene patient examination glove||I||OPC||880.6250|
|Patient examination glove, specialty||I||LZC||880.6250|
|Radiological examination glove, specialty||I||SPO||880.6250|
|Powder-Free Non-Natural Rubber Latex Surgeon’s Gloves||I||Takeover bid||878.4460|
|Guayle powder-free rubber examination glove||I||BIG||880.6250|
|Latex patient examination glove||I||LYY||880.6250|
|Vinyl patient examination glove||I||LYZ||880.6250|
In March 2020, to address the lack of personal protective equipment (PPE) caused by COVID-19, the FDA suspended 510 (k) pre-market notification requirements for a variety of gloves, including the categories listed. above. In his “Policy for applying gowns, other clothing and gloves during coronavirus disease (COVID-19) Public health emergency, Released in March 2020, the FDA effectively waived various compliance and quality regulations for surgeon and patient examination gloves, including the 510 (k) pre-market notification. The HHS compared adverse reactions reported through the FDA’s MAUDE system before March 2020 and after the publication of the enforcement policy. Based on this information, HHS has determined that since a minimum number of adverse events related to the seven product codes listed above have been reported since the publication of the Enforcement Policy, prior notification to market 510 (k) was no longer required for these devices.
During the duration of the COVID-19 public health emergency, the enforcement policy waived other regulatory requirements for examination gloves, for example, registration and listing and reporting of corrections and deletions. However, it is important to note that once the public health emergency is lifted, these regulatory requirements are not affected by the January 15 HHS advisory. Therefore, manufacturers and responsible parties in the supply chain will need to be on high alert and ready to return to compliance with all applicable regulations.
The advisory also identified 84 additional Class II devices that the HHS proposed to exempt from 510 (k) pre-market notification requirements. Some of the Class II devices include additional PPE such as the Pediatric / Child Face Mask (OXZ); N95 respirator with antimicrobial / antiviral agent for use by the general public in public health medical emergencies (ORW); N95 respirator with antimicrobial / antiviral agent (OKC); Surgical mask with antimicrobial / antiviral agent (OUK); and Gown, Isolation, Surgical (FYC). Under the notice, the exemption could have come into effect by the end of March 2021. However, on January 20, 2021, President Biden’s chief of staff issued the memorandum “Regulatory freeze awaiting review. “The memorandum ultimately prevents the HHS advisory from coming into effect with respect to the 84 Class II devices unless it is approved by the new administration, which is unlikely.