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Medical Devices / Regulatory Affairs / Submissions and Approvals

FDA to Exempt Surgical Apparel from 510(k) Requirements

Dec. 7, 2017

Single-use, disposable respiratory protective devices used in healthcare settings by medical professionals may soon be exempt from premarket notification requirements.

The FDA is proposing to exempt the devices intended to protect patients and hospital staff from the transfer of microorganisms, body fluids, and particulate material, subject to certain limitations. They are currently regulated as class II (special controls) devices.

The 21st Century Cures Act gave the agency authority to exempt class II devices from requiring 510(k) submissions if it can determine that a 510(k) clearance is not necessary to assure their safety and effectiveness.  

All other class II devices classified under the FDA’s surgical apparel classification regulation would continue to be subject to premarket notification requirements, the agency said.

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