FDA Exempts Surgical Apparel From 510(k) Requirements

Regulatory NewsRegulatory News | 16 May 2018 |  By 

Single-use, disposable respiratory protective devices intended for medical professionals’ use in healthcare settings will no longer be subject to premarket notification requirements, following an order the US Food and Drug Administration (FDA) finalized Wednesday.
The final exemption order—proposed last December—is intended to reduce regulatory burden on manufacturers of the class II (special controls) devices and eliminate the associated costs.
The exempted devices, otherwise known as N95 filtering facepiece respirators and surgical N95 respirators, fall under the umbrella of surgical apparel and are designed to protect patients and hospital staff from the transfer of microorganisms, body fluids and particulate material.
As part of the final order, certain limitations apply for the respiratory protective devices to be exempt from 510(k) review. The conditions—outlined in a Memorandum of Understanding between the FDA and the Centers for Disease Control and Prevention's (CDC) National Institute for Occupational Safety and Health (NIOSH)—include applications to NIOSH not exceeding the FDA-CDC agreed upon threshold evaluation criteria, as well as receiving NIOSH approval.
The final order also provides definitions for the two different types of respiratory protective devices. All other devices under the FDA’s surgical apparel classification regulation will continue to be subject to premarket notification requirements.
Following the additional regulatory authority the 21st Century Cures Act of 2016 granted to the FDA, the agency has moved to issue exemptions on a deluge of class I and class II devices, ranging from genetic health risk assessment systems to endoscopic maintenance systems.
In March, the FDA also issued a final exemption order on over-the-counter denture repair kits.
Further, more than 70 class I medical devices and a set of 1,003 class II medical devices became exempt from 510(k) requirements in April and July 2017, respectively.
Exemptions are pursued if the agency believes that a premarket notification for the device type is not necessary to provide reasonable assurance of its safety and effectiveness.
Medical Devices; Exemption From Premarket Notification: Class II Devices; Surgical Apparel


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