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Regulatory Focus™ > News Articles > FDA Down-Classifies Colon, Intravascular Devices

FDA Down-Classifies Colon, Intravascular Devices

Posted 15 May 2014 | By Alexander Gaffney, RAC

FDA Down-Classifies Colon, Intravascular Devices

The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) has proposed that two medical devices marketed prior to the 1976 Medical Device Amendments to the Federal Food, Drug and Cosmetic Act (FD&C Act) be subject to less stringent regulation.

In two separate Federal Register announcements, FDA said it would permit intravascular administration sets and colon capsule imaging systems, respectively, to be classified as Class II devices under the FD&C Act.

The devices, having been approved prior to the Medical Device Amendments, had been classified as Class III—high risk—devices subject to premarket approval (PMA) requirements.

Under the new classifications, they will be subject to premarket notification requirements [510(k)] along with general controls and special controls meant to ensure that they are safe and effective, but without the need to conduct extensive clinical trials.

Both orders will be made final 30 days after 16 May 2014.

Medical Devices: Classification of the Colon Capsule Imaging System

Medical Devices: Classification of the Intravascular Administration Set, Automated Air Removal System


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