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FDA Exempts Some Respirators From Premarket Notification
Devices Regulatory Affairs
The FDA issued an order exempting certain surgical apparel from premarket notification requirements.
The exemption is for single-use, disposable respiratory protective devices (RPD) worn by healthcare personnel during procedures to protect the patients and themselves from the transfer of microorganisms, body fluids, and particulate material.
Commonly referred to as N95 filtering facepiece respirators and surgical N95 respirators, the devices are currently regulated by FDA under product code MSH.
All other Class II devices under FDA’s surgical apparel classification continue to be subject to premarket notification requirements, the agency said.