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Project

Medical Device Initiative

Status:
Active

MedPage Today: FDA Mulls Faster OK for High-Need Devices

Media Coverage

The FDA wants to create an expedited approval pathway for high-risk medical devices for unmet needs, saying current tools at its fingertips are ineffective for speedier approvals. More

The Hill: Coming Soon: IDs to Track Medical Devices

Opinion
  • Nov 19, 2013
  • The Hill

Congressional hearings on health care can be contentious, but the story will be different today (November 19), when the bipartisan House Medical Technology Caucus convenes a forum with representatives from the U.S. Food and Drug Administration , manufacturers, and hospitals to discuss how new tracking codes for medical devices can enhance recalls and assessments of heart stents, glucose monitors, and other products patients need. More

Reuters: U.S. FDA Issues Final Rule on Medical Device Identifier Codes

Media Coverage

"The U.S. Food and Drug Administration issued a long-awaited rule on Friday requiring companies to include codes on medical devices that will allow regulators to track the products, monitor them for safety and expedite recalls."

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AP: FDA Requires Unique Codes to Track Medical Devices, Improve Recalls and Patient Safety

Media Coverage

"Federal health regulators will begin tracking millions of medical devices, from pacemakers to hip replacements, using a new electronic system designed to protect patients by catching problematic implants earlier."

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Pew Commends FDA for Releasing Final Medical Device Identifier Rules, Outlines Next Steps

Press Release
  • Sep 20, 2013

The Pew Charitable Trusts today commended the U.S. Food and Drug Administration for issuing final regulations establishing a unique device identifier (UDI) system to mark medical devices or their labels with a code corresponding to the products’ make, model and other clinically relevant information. More

''Groups Call on FDA for Final Device ID Rule''

Media Coverage

"Medical groups and patient advocates are clamoring for the FDA to release a final rule requiring most medical devices distributed in the U.S. to carry a unique alphanumeric code allowing for better information tracking."

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''Move Forward on Medical Device Tracking''

Opinion
  • Jun 26, 2013
  • Minneapolis Star-Tribune

'You may not yet depend on a pacemaker, defibrillator, stent, joint implant or any of the other life-­changing, potentially lifesaving products made by the medical device industry. But chances are you or a family member will be a patient some day.  That’s why it isn’t just the medical device industry that has a stake in the timely rollout of a long-overdue national system to better track the safety and whereabouts of devices once they’re on the market or in use."

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''Medical Malfunction: Innovation vs. Quality Control''

In the News
  • Mar 26, 2013

"Dr. Emily Senay appeared on MSNBC's "Morning Joe" to discuss faulty medical devices and how they slip through the cracks of manufacturers and the FDA."

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''Need to Know: Medical Devices''

Media Coverage

The PBS program "Need to Know" devoted a portion of their March 22 program to discuss medical devices. Joining host Jeff Greenfield on the program was Pew's Dr. Josh Rising, project director of the medical devices initiative at The Pew Charitable Trusts.

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''The Loophole That Keeps Precarious Medical Devices in Use''

Media Coverage

The U.S. Food and Drug Administration announced last month that it will classify metal-on-metal hip implants as high-risk devices. That comes after the artificial joints were found to have failed at high rates, causing disability and meaning additional surgery for thousands of people. But hundreds of other potentially high-risk medical devices remain in use without what many consider to be adequate testing

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''Let The Sunshine In: CMS Releases Transparency Rule''

Media Coverage

"After 15 months of delay, the Centers for Medicare & Medicaid Services has finally released the long-awaited Sunshine Act rule, which establishes procedures for gathering and publishing data containing financial ties between physicians, teaching hospitals and drug and device makers, as well as group purchasing organizations."

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''F.D.A. Seeks to Tighten Regulation of All-Metal Hip Implants''

In the News
  • Jan 22, 2013

"After an estimated 500,000 patients in the United States have received a type of artificial hip that is failing early in many cases, the Food and Drug Administration is proposing rules that could stop manufacturers from selling such implants."

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''Drug, Device Makers Anxiously Await U.S. Doctor-Payment Disclosure Rule''

Media Coverage

''Drug and medical-device makers are bracing for a new U.S. rule that will require them to report physician-payment information to the government--a rule some companies and doctors fear will be overly broad and could mislead the public.''

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''FDA Stakeholders Worry About Sequestration''

Media Coverage

"Representatives from the FDA and industry expressed serious concerns about the potential impact of sequestration Monday, saying it's not a good time to shortchange the agency when it's under so much pressure to help bring innovative new drugs to market."

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Seeking Better and Safer Medical Devices

In the News
  • Oct 1, 2012

Medical devices range from common iteams such as stethoscopes to more complex products such as pacemakers and heart stents. The Medical Device Initiative project seeks to improve the tracking of medical device safety and to foster innovation that benefits patients. Project Director Josh Rising has a personal connection to the value of medical devices and he explains the importance of the Initiative and the goals of the program.

 

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