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Posts tagged ‘FDA Medical Devices’

On January 16, 2015, the U.S. Food and Drug Administration (FDA) issued a draft guidance regarding FDA’s Center for Devices and Radiological Health’s (CDRH) compliance policy for general wellness products.  According to the guidance, CDRH does not plan to regulate general wellness products for compliance with medical device regulations, including registration, listing, premarket notification, labeling, […]

On January 14, 2015, the U.S. Food and Drug Administration (FDA) hosted two webinars to assist Class II and implantable, life-supporting and life-sustaining device labelers, as well as new Class III device labelers with Unique Device Identifier (UDI) and Global Unique Device Identification Database (GUDID) requirements.  Class III device labelers are currently required to comply […]

Over the past two days, Registrar Corp has published year in review blogs about FDA regulations for food and drug companies. Today we’re reviewing FDA’s medical device regulations and guidances established in 2014. August 1:  FDA proposed to exempt over 100 devices from 510(k) requirements.  FDA indicated that it will not enforce 510(k) requirements for […]

In 2009, the U.S. Food and Drug Administration (FDA) launched a Mini-Sentinel pilot program. The program was launched as part of the Sentinel Initiative, which aims to create a new and improved system of tracking the safety of FDA-regulated drugs and medical devices.  Five years later, the Mini-Sentinel program is transitioning into a full-scale operation […]

The classification of a medical device can change as more information is gathered about the device.  In order to have a device reclassified to a lower class, the device manufacturer must prove to the U.S. Food and Drug Administration (FDA) that lower class requirements will provide adequate safety and effectiveness through a petition.   On December […]

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