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US FDA Ramping up Permanent 510(k) Exemptions for Dozens of Medical Devices

Nearly 100 low- and moderate-risk medical devices may soon be exempt from 510(k) premarket notification requirements in the US, according to a new FDA notice.

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January 25, 2021

The US Food and Drug Administration has permanently exempted seven types of low-risk medical devices from 510(k) premarket notification requirements, and has proposed similar exemptions for several other device types to expand access to these products during the COVID-19 public health emergency. 

According to a recent FDA notice, the seven Class I device types permanently exempt from 510(k) requirements include surgical and examination gloves; these exemptions took effect January 15, 2021.

Learn how medical device markets are reacting to COVID-19

Additional Class II device exemptions targeted

In addition, the agency has proposed permanent exemptions from 510(k) registration requirements for 83 Class II devices (as well as one unclassified device); a lack of adverse event report data on these devices led FDA to deem premarket notification unnecessary. The regulator had opened a 60-day comment period on these proposed further exemptions.

Types of devices targeted by the permanent 510(k) exemption proposal include a wide range of products and systems: home-use ventilators, airway monitoring systems, OTC electrocardiograph software, air purifiers and cleaners, medical device cleaners, N95 respirators and oxygenators. Table 6 of the FDA notice provides a full list of Class II and unclassified devices identified for exemption.

As well as supporting increased public access to devices needed during the coronavirus pandemic, these new and proposed 510(k) exemptions would allow FDA to dedicate regulatory review resources to more mission-critical areas, including towards devices and technologies to combat COVID-19.

Related COVID-19 and US FDA medical device regulatory resources:

  • US FDA 510(k) consulting for medical device and IVD companies

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