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FDA Proposes Certain Accessories Be Defined As Class I Devices

August 16, 2018

The FDA issued a list of medical device accessories that it proposes to categorize as Class I and requested public feedback on the proposed list.

Class I devices are consider low risk and require only general controls while Class II devices require special controls and Class III devices require premarket approval by the agency.

Some of the listed devices include ureteral stent accessories, biliary stent, drain and dilator accessories, suprapubic catheter accessories and corneal inlay inserter handles.

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