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The IRB at a major Chicago hospital has been handed an FDA warning letter for a slew of violations in a device clinical trial, many of which were first observed at the site over a decade ago. Read More
Sponsors conducting clinical trials in India must fully inform study patients about potential payments resulting from adverse events during videotaped informed consent sessions, a draft guideline says. Read More
Devicemakers should note whether changes to PMA devices were due to enhancement, product complaints or adverse events when preparing annual reports for the FDA, new guidance released Friday says. Read More
Industry hopes that new Russian device regulations would speed up the pace of registrations and approvals have paled as regulators struggle to create implementing guidance. The regulations took effect in January 2013, but have yet to be fully enacted. Read More
Four employees of a medical device company who pleaded guilty to withholding side effect information in an IDE got off relatively easy in their settlement agreements, attorneys say. Read More
A year-long effort to refine CDRH’s research mission and get more bang for the buck is showing positive results, but one goal — using metrics to track success — remains elusive, Director Jeffrey Shuren told a gathering of the FDA’s Science Board. Read More
The FDA will create a device-only enforcement unit that promises more consistent inspections and enforcement decisions with fewer bureaucratic hurdles for investigators to issue warning letters. Read More
An HHS final rule permitting patients direct access to their laboratory test reports will not have many direct consequences for Dx makers, but could result in more patients blaming manufacturers for incorrect test results, an industry expert says. Read More
Pricing of durable medical equipment, data security and clinical lab test fees are all slated for government scrutiny this year, according to the HHS Office of the Inspector General’s fiscal 2014 work plan. Read More
In deciding to reorganize the Office of Compliance, CDRH made the pragmatic decision to focus its limited resources on encouraging quality rather than on compliance enforcements, OC Director Steve Silverman says. Read More
The FDA has updated the list of consensus standards it references during premarket reviews. The dozens of revisions touch on areas including software, biocompatibility testing, orthopedics and anesthesia. Read More