In order to increase the availability of certain Medical Devices in contrast to the COVID-19 health emergency, on January 15, 2021 FDA published a notice in the Federal Register which highlights the relaxation of numerous regulatory, including a waiver of Premarket Notification 510(k) requirements, that is, the Premarket notification requirements under section 510(k).
For seven Class I Medical Devices it has been provided permanent exemption from the Premarket Notification 510(k) requirements, as products have not shown adverse events and they have been assessed as sufficiently safe and effective.
Which Class I devices are now exempt from the Premarket Notification 510(k) requirements?
|Medical Device description||Class of the Medical Device||Product Code||Section 21 CFR|
|Powder-Free Polychloroprene Patient Examination Glove||I||OPC||880.6250|
|Patient Examination Glove, Specialty||I||LZC||880.6250|
|Radiation Attenuating Medical Glove||I||OPH||880.6250|
|Powder-Free Non-Natural Rubber Latex Surgeon”s Gloves||I||OPA||878.4460|
|Powder-Free Guayle Rubber Examination Glove||I||OIG||880.6250|
|Latex Patient Examination Glove||I||LYY||880.6250|
|Vinyl Patient Examination Glove||I||LYZ||880.6250|
Further proposed exemptions for Class II devices
By virtue of lack of adverse event reports, FDA also proposed exemptions for 83 Class II Medical Devices and one unclassified device.
Medical Devices that are the subject of these proposals include a wide range of products and systems, such as N95 respirators, MD detergents and software for electrocardiography.
The complete list of these devices has been published in the table n° 6 of the FDA notice on the Federal Register.
Thanks to these exemptions, FDA could ensure increased availability of Medical Devices and technologies useful to counter the COVID-19 pandemic.
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