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As the shortage in medical use personal protective equipment continues amid the coronavirus disease (COVID-19) pandemic, the US Food and Drug Administration (FDA) is lifting requirements for certain masks and respirators to increase their availability.

For face masks intended for medical purposes, FDA says it is lifting major regulatory requirements to increase availability of the devices, including 510(k) submission, so long as the devices do not create an undue risk for users.

FDA says it will allow the distribution and use of surgical masks, which are Class II devices, without 510(k) clearance, given that the masks meet certain standards for fluid resistance and flammability and include accurate labelling.

Typically, re-processors must obtain 510(k) clearance to reprocess single use devices. However, given the urgent need for respirators, FDA says it will work with companies to expedite the EUA process and provides a detailed list of information for companies to provide to support an EUA request.

In early Dec 2020, SGS had been recognized by FDA to be a official 510(k) Third-Party Review Organization (see here for the announcement). 

SGS provides a Comprehensive Solution for Mask Quality, including ISO 14644 cleanroom certification, EN 14683 / ASTM F2100 product testing, pre-shipment inspection, ISO 13485 medical device quality management system certification and overall project management.  For more details on our services, please see here.

For more information on FDA’s clarification on Medical Mask Sample Size Requirements for 510(K), please see here.

SGS’s medical device testing, certification, audit and training services can help you navigate the complexities of international medical device regulations to bring your products to market while ensuring compliance with the required regulations and standards and providing a high level of safety to patients and healthcare professionals. 

For enquiries, please contact our Customer Service team!

To obtain a copy in PDF, please click here.