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.

Would you like more information about 510 (k)?

Rely on Thema experts for a valuable strategic-regulatory consultancy.
Contact us and find out what we can do for you.

Source:

 FDA notice on the Federal Register