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Regulatory Focus™ > News Articles > Eight Additional Device Classes Exempt from Premarket Notification Requirements

Eight Additional Device Classes Exempt from Premarket Notification Requirements

Posted 14 August 2015 | By Michael Mezher 

Eight Additional  Device Classes Exempt from Premarket Notification Requirements

In July, the US Food and Drug Administration exempted some 120 medical device classes from its premarket notification and review requirements. Now, FDA has announced it is exempting additional device classes from these requirements, after an administrative error caused the agency to miss some comments from a public consultation.


In 2012, during the third Medical Device User Fee Act (MDUFA) talks, FDA committed to reducing regulation on certain low-risk devices, promising the agency would exempt some devices from premarket notification by the end of FY2013, and expand the list within two years of the act's authorization.

In July 2015, FDA made good on its promise by issuing a guidance declaring the agency's intent to exempt 120 device classes from premarket notification requirements. The guidance also stated the agency would no longer "enforce compliance with 510(k) requirements" for the exempted devices until the exemptions could move through the formal notice and rulemaking process.

For a full list of the original 120 exempted device classes see Focus article "FDA Exempts 120 Medical Device Types from Most Regulation"

Newly Exempted Classes

Today, FDA updated its guidance document Intent to Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices from Premarket Notification Requirements to include an additional eight device classes. The classes are as follows:

DTL – Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

OCY - Endoscopic Guidewire, Gastroenterology-urology

KOE - Dilator, Urethral

FTA – Light, Surgical, Accessories

GZM – Analyzer, Rigidity

GZO - Device, Galvanic Skin Response Measurement

HCJ - Device, Skin Potential Measurement

HLJ - Ophthalmoscope, Battery-powered




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