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Drugs and Devices at the FDA

Pew Leadership: Senate Committee Testimony
Issue Brief

Pew Leadership: Senate Committee Testimony

FDA User Fee legislation
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Drugs and Devices at the FDA News & Resources

Letter from Pew and Premier to the OMB on Unique Device Identifier Rule

Issue Brief Jul 8, 2013 Medical Device Initiative

The Pew Charitable Trusts and the Premier healthcare alliance sent the White House Office of Management and Budget a letter regarding the review of a Food and Drug Administration rule to establish a unique device identifier (UDI) system. Given the importance of this new device identification system to improve patient care and the missed statutory deadline, in this correspondence Josh Rising of Pew and Blair Childs of Premier strongly urged the Director of the Office of Management and Budget (OMB) to promptly complete review of the UDI final rule.

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Letter from Pew: Release of the Unique Device Identifier Final Rule

Issue Brief Jun 27, 2013 Medical Device Initiative
A letter from Josh Rising — director of Pew's Medical Device Initiative — to The White House Office of Management and Budget, requesting a speedy review of regulations to develop a unique device identifier (UDI) system. More

''Move Forward on Medical Device Tracking''

Opinion Jun 26, 2013 Medical Device Initiative

'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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Letter from Pew: Updates on the Unique Device Identifier System

Issue Brief Jun 18, 2013 Medical Device Initiative

A letter from Josh Rising, director of Pew's Medical Device Initiative, about updates on the unique device identifier system.

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Letter from Pew to FDA on Postmarket Surveillance Plan

Issue Brief May 30, 2013 Medical Device Initiative
FDA recently updated the national medical device postmarket surveillance plan – listing device identification and registries as the cornerstones for effective product monitoring. In this letter, medical devices director Josh Rising applauds the agency for making unique device identifiers and registries central to this plan.
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Letter From New Democrat Health Care Task Force to FDA on Unique Device Identification System

Issue Brief Apr 25, 2013 Medical Device Initiative

The three co-chairs of the New Democrat Health Care task Force – Reps. Allyson Schwartz, Kurt Schrader and Bill Owens – sent FDA a letter inquiring about the status of the agency’s final regulations to establish a unique device identifier (UDI) system and database.

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National Public Health Week

This year's celebration of National Public Health Week (NPHW) focuses on the theme, "Public Health is ROI: Save Lives, Save Money." Join us in recognizing the work of Pew's Health Initiatives. More

''Need to Know: Medical Devices''

Media Coverage Mar 26, 2013 Medical Device Initiative

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 Feb 27, 2013 Medical Device Initiative

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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One Step Closer to Medical Transparency: Pew's Analysis of the Final Rule for the Physician Payments Sunshine Act

Other Resource Feb 19, 2013 Pew Prescription Project
On Feb. 1, 2013, the Centers for Medicare & Medicaid Services published the final rule guiding implementation of the Physician Payments Sunshine Act, which Congress passed as part of the Affordable Care Act in March 2010 to increase transparency in the relationships between physicians and drug and medical device makers. Here are some of the highlights. More

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