Search Results for Class I

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FDA Pushes Back Enforcement of UDI Requirements for Class I, Unclassified Devices By Zachary Brennan - Published 12 January 2018

The US Food and Drug Administration (FDA) said Friday that it will delay its enforcement of certain unique device identification (UDI) system requirements for class I and unclassified devices by two years.

Categories: News, US, CDRH, Compliance, Due Diligence, Government affairs, Medical Devices

Tags: unique device identification, Class I, unclassified devices, UDI enforcement

Device Recalls in 2017: Making Sense of the Numbers By Michael Mezher - Published 10 January 2018

Each year, the US Food and Drug Administration (FDA) designates anywhere from dozen to hundreds of medical device recalls as Class I, indicating that the risk addressed by the recall could potentially cause serious injury or death.

Categories: News, US, FDA, In vitro diagnostics, Medical Devices

Tags: Recalls, Corrections, Removals, Class I Recall

FDA Identifies More Than 70 Class I Devices Now Exempt From 510(k) Requirements By Zachary Brennan - Published 12 April 2017

As part of its implementation of the 21st Century Cures Act, the US Food and Drug Administration (FDA) on Wednesday released a list of more than 70 Class I medical devices that are now exempt from premarket notification requirements.

Categories: News, US, FDA, Government affairs, In vitro diagnostics, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: 21 Century Cures, Class I devices, medical devices

FDA Provides New Guidance on Whole Slide Imaging Devices By Alexander Gaffney, RAC - Published 25 February 2015

New draft guidance issued by the US Food and Drug Administration (FDA) offers a high-level roadmap for developers of digital imaging devices known as digital pathology whole slide imaging devices.

Categories: News, US, CDRH, Compliance, Medical Devices

Tags: Guidance, Draft Guidance, Digital Pathology Whole Slide Imaging Device, WSI, Class I

British Regulators Launching Online Registration System for Low-Risk Devices By Stewart Eisenhart, Emergo - Published 03 February 2015

The British Medicines and Healthcare products Regulatory Agency (MHRA), responsible for overseeing the UK’s medical device market, is launching a new online registration system for low-risk devices on 11 February 2015.

Categories: News, Europe, MHRA, In vitro diagnostics, Medical Devices, Submission and registration

Tags: Class I, Devices Online Registration System, DORS

The Future Will be Regulated: FDA Asks for More Information on Robotic Exoskeleton By Alexander Gaffney, RAC - Published 04 December 2014

The future is here. The future will be regulated. Those are two possible conclusions from an announcement this week by Ekso Bionics, which said its robotic exoskeleton—intended to help paralyzed patients walk by augmenting their strength—must meet additional regulatory requirements put in place by the US Food and Drug Administration (FDA).

Categories: News, US, CDRH, Compliance, Medical Devices, Submission and registration

Tags: 510(k), Premarket Notification, Robotic Exoskeleton, Ekso, Ekso Bionics, Class I

Massive Recall of Medical Devices Largest Ever Recorded by FDA By Alexander Gaffney, RAC - Published 02 September 2014

A massive medical device recall reported last week by the US Food and Drug Administration (FDA) is the largest-ever single-day event on record, according to data recently made available by FDA.

Categories: News, US, CDRH, Medical Devices, Packaging, Product withdrawl and retirement

Tags: Recall, Medical Device Recall, Sterility, Packaging, Class I Recall

Number of Drug Recalls Surges at FDA, Led by Mid-Level Concerns By Alexander Gaffney, RAC - Published 11 August 2014

Recalls of pharmaceutical products have surged in recent years, and 2014 is already shaping up to be the biggest year for serious drug recalls in the last decade, according to data made publicly available by the US Food and Drug Administration (FDA) late last month.

Categories: News, US, CDER, Drugs, Postmarket surveillance, Product withdrawl and retirement

Tags: Recall, Drug Recalls, FDA Recalls, Drug Recalls Increasing, Class I Recall, Class II Recall, Class II Recall

Regulators Extend Comment Period on Proposed Overhaul of Device Reclassification System By Alexander Gaffney, RAC - Published 11 June 2014

The US Food and Drug Administration (FDA) is extending by several months the comment period on a proposed rule which would make it easier for the agency to classify and reclassify medical devices in accordance with their perceived risk.

Categories: News, US, CDER, In vitro diagnostics, Medical Devices

Tags: Device Classification, Device Reclassification, Medical Device Classification Procedures, Rule, Proposed Rule, Comment Period, Class I, Class II, Class III

Hospira Initiates Class I Recall for Touchscreen, Software Issues By Alexander Gaffney, RF News Editor - Published 30 October 2012

Tags: Class I Recall, Hospira, Recall, Latest News, medical device

Study: FDA Recall Communication System Ineffective, Poorly Designed By Alexander Gaffney - Published 06 June 2012

Categories: FDA

Tags: Dear Doctor Letter, Recall Alert System, Archives of Internal Medicine, Class I, MedWatch, Latest News, recalls, study