Search Results for device data

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Asia Regulatory Roundup: TGA Provides Guidance as Black Triangle Scheme Goes Live (16 January 2018) By Nick Paul Taylor - Published 16 January 2018

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: News, Asia, CDSCO, CFDA, TGA, Biologics and biotechnology, Drugs, Medical Devices

Tags: Asia Regulatory Roundup, black triangle, device data, recalls

FDA Finalizes Two Guidances on Sharing Device Data With Patients, Aspirator Device Labeling By Zachary Brennan - Published 27 October 2017

The US Food and Drug Administration (FDA) on Friday finalized two guidance documents, including one related to medical device manufacturers sharing information with patients upon request, and another to recommend the addition of a specific safety statement to the product labeling of certain ultrasonic surgical aspirator devices.

Categories: News, US, FDA, Government affairs, Medical Devices

Tags: device data sharing, ultrasonic surgical aspirator devices

IMDRF Consults on Use of Registries to Support Device Approval Decisions By Zachary Brennan - Published 02 October 2017

The International Medical Device Regulators Forum (IMDRF) has opened for consultation until 1 December a third document on examining the use of registries to support medical device regulatory decision making.

Categories: News, Asia, Canada, Europe, US, IMDRF, In vitro diagnostics, Medical Devices, Postmarket surveillance, Regulatory intelligence, Regulatory strategy

Tags: registry data and medical devices, medical device data, approval decisions and registries

FDA to Publicly Disclose ‘Emerging Signals’ Info for Medical Devices By Zachary Brennan - Published 13 December 2016

The public will soon see more prompt notifications on medical device risks and potential risks thanks to guidance finalized Tuesday by the US Food and Drug Administration (FDA).

Categories: News, US, CDRH, Compliance, Crisis management, Ethics, Medical Devices, Regulatory intelligence, Submission and registration

Tags: emerging signals, medical device risks, medical device data, FDA publishing medical device data

Medical Device Data Systems to be Exempt from Regulation, FDA Says By Alexander Gaffney, RAC - Published 20 June 2014

In a stark reversal, US Food and Drug Administration (FDA) regulators today said they would exempt medical device data systems (MDDS)—systems used to collect and store data from other medical devices like weight scales and glucose meters—from regulation, abandoning an earlier plan to regulate them as Class I ("low-risk") medical devices.

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

Tags: MDDS, Medical Device Data Systems, Exempt from Regulation, Mobile Medical Applications, Guidance, Draft Guidance, Medical Image Storage Device, Medical Image Communications Device