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  • Regulatory NewsRegulatory News

    Australia Unveils Device Action Plan

    Australia’s Therapeutic Goods Administration (TGA) released a three-part medical device action plan, part of which will make adverse event reports more timely, as well as enhance public awareness on and the agency and device regulatory system. The plan also identifies additional opportunities for TGA to increase transparency, with stakeholder consultations on proposed changes to regulatory requirements and forthcoming guidance materials. Until early 2020, potential c...
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    FDA Panel Recommends New Postmarket Requirements for Breast Implants

    As part of efforts to make breast implants safer, the US Food and Drug Administration (FDA) should consider additional postmarket data reporting requirements on breast implant manufacturers, the agency’s General and Plastic Surgery Devices Panel suggested after a two-day meeting. On whether to remove textured breast implants from the US market as other countries have done, the panel argued data is lacking to support such a recommendation as it would reduce options for p...
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    Breast Implant Manufacturers Draw FDA Warning Letters Over Post-Approval Studies

    The US Food and Drug Administration (FDA) sent warning letters this week to two breast implant manufacturers over their failures to comply with FDA’s post-approval study (PAS) requirements. The warning letters were made public by FDA late Tuesday and sent to Sientra and Mentor Worldwide on Monday for being in violation of two of the seven requirements established as part of their devices’ conditional approvals. They underscore an emerging FDA enforcement trend around PA...
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    FDA Flags Higher Death Rates Linked to Use of Abiomed Heart Pump in Post-approval Study

    A temporary heart pump manufactured by Massachusetts-based Abiomed prompted a US Food and Drug Administration letter to health care providers on Monday over an increased rate of mortality. The letter cites interim results from Abiomed’s January report on a post approval study (PAS) that was mandated by the agency as a condition for the 2017 FDA approval of the Abiomed Impella RP System. “A total of 44 out of 60 patients (73.3%) survived to 30 days post device explant...
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    Sentinel: FDA Outlines Five-Year Roadmap

    As the US Food and Drug Administration's (FDA) Sentinel Initiative approaches its 11 th anniversary, the agency on Wednesday laid out its vision for enhancing the system over the next five years.   First launched as a pilot program in 2008, the Sentinel Initiative encompasses FDA’s effort to meet obligations set by Congress in the 2007 Food and Drug Administration Amendments Act to develop a system for active postmarket risk identification and analysis for medical p...
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    Health Canada Details Medical Device Action Plan

    Health Canada issued a new action plan on Thursday, detailing a three-part strategy intended to improve safety, oversight and quality in the Canadian medical device ecosystem.   The move follows on the heels of an International Consortium of Investigative Journalists investigation into patient harm linked to surgically implanted medical devices. The investigation  prompted  the Canadian Minister of Health to call on Health Canada to address premarket approval processes...
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    WHO Finds Wide Disparities in Antibiotic Use Between Countries

    A new report from the World Health Organization (WHO) published Monday reveals major differences in the amount of antibiotics consumed by countries around the world and calls for changes in how countries monitor and use antimicrobial drugs.   “Overuse and misuse of antibiotics are the leading causes of antimicrobial resistance. Without effective antibiotics and other antimicrobials, we will lose our ability to treat common infections like pneumonia,” said Suzanne Hill,...
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    First Version of NEST to Launch in 2019

    The National Evaluation System for health Technology (NEST) will become increasingly crucial for tracking medical devices at FDA’s Center for Devices and Radiological Health (CDRH), though its creation continues to be fraught with limitations. The timeline for an initial version of the NEST Coordinating Center (NESTcc) is tight, Rachel Fleurence, NESTcc executive director, noted Wednesday at the MDEpiNet annual meeting at FDA’s White Oak campus. The idea for NEST origina...
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    Fears Over Device Surveillance Amid Talk of Deregulation

    A team of researchers say that better postmarketing data for medical devices could identify safety issues sooner, but they fear that current political headwinds could derail planned device safety efforts. In a viewpoint published in JAMA on Thursday, Joshua Sharfstein of Johns Hopkins Bloomberg School of Public Health, and Rita Redberg and Alison Jacoby of the University of California, San Francisco Medical Center, point to the recent debate over power morcellators as ...
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    FDA Finalizes Guidance on Postmarket Device Surveillance

    The US Food and Drug Administration (FDA) on Friday finalized guidance (five years after draft guidance was first released) for device manufacturers on its interpretation of the law with regard to postmarket surveillance of certain class II or class III devices. The guidance comes as the Government Accountability Office (GAO) said last October that 90% of the postmarket surveillance studies FDA ordered over the past seven years were categorized as inactive, though some...
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    Plans for US Evaluation System for Medical Devices Take Root

    The US Food and Drug Administration (FDA) is going to make a big push over the next two years to use more real-world evidence to track the safety of medical devices. The plan, outlined in FDA’s Center for Devices and Radiological Health’s (CDRH) Strategic Priorities report for 2016-2017, will see the agency building a national medical device evaluation system as part of efforts to leverage real-world evidence to more quickly identify safety signals, particularly through ...
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    GAO Finds Majority of Postmarket Surveillance Studies FDA Ordered for Devices are Inactive

    Nearly 90% of the postmarket surveillance studies the US Food and Drug Administration (FDA) ordered over the past seven years were categorized as inactive, though some of these studies were added to other ongoing studies, according to a new Government Accountability Office (GAO) report. Rep. Rosa DeLauro (D-CT) requested the GAO look into the postmarket studies of devices ordered by FDA, and this latest report investigates the types of devices for which FDA has ordered a...