• Shuren: CDRH Actively Assessing 3D Printing, Expect Guidance Within Next Two Years

    Technological advancements happen quickly in the medical device space-a fact the US Food and Drug Administration (FDA) has long struggled with as it seeks to stay abreast of cybersecurity threats and trends in mobile computing. But when it comes to one of the newest trends of all, 3-D printing, what is the agency planning on doing? Guidance Coming in Less Than Two Years Pay close attention in the next two years for the answer to that question, said Jeffery Shuren, direc...
  • FDA Data Show the Worst is Over for 510(k), PMA Submissions

    The medical device industry has long complained that the process of obtaining regulatory approval for its devices has become increasingly difficult over the course of the last decade. But in a presentation given to industry at a recent device conference, the US Food and Drug Administration's chief medical device regulator Jeffery Shuren had a message for manufacturers: The worst is over. 510(k): The Worst is Over Shuren, the director of FDA's Center for Devices and Radi...
  • Reporting Adverse Events? There's an App for That, But Not for Industry--Yet

    Need to report an adverse event related to a medical device? Now patients are about to find there's an app for that, US regulators revealed yesterday. Background The US Food and Drug Administration (FDA) takes in an enormous number of adverse event reports each year through various systems, including MedWatch . One issue, however, is that manufacturers, healthcare providers and patients are held to different standards. Medical device manufacturers, for example, are h...
  • CDRH Publishes List of Projects and Guidance Documents Planned for 2013 Completion

    It's that time of year-the holidays, yes, but also when companies and agencies are putting the final touches on their planning documents for 2013. The US Food and Drug Administration (FDA) is no exception to this trend, and its Center for Devices and Radiological Health (CDRH) has just published its 2013 Strategic Priorities plan. Calling the plan a continuation and expansion of its efforts to promote "smart regulation," CDRH said it is reorganizing its plan to better ...
  • Department of Justice Seeks Dismissal of Whistleblowers' Case Against FDA

    The Department of Justice (DOJ) has filed a motion to dismiss a lawsuit brought against the US Food and Drug Administration (FDA) by several current and former agency employees after FDA allegedly spied on their whistleblowing activities to members of Congress and other oversight agencies. DOJ's motion, filed on 1 October-almost exactly a year after the case was first filed-seeks dismissal based on a "lack of jurisdiction." Bloomberg explains DOJ argues that an...
  • Legislators Call for Publicly Available 510(k) Database to Address 'Loophole'

    Two legislators have written to the US Food and Drug Administration's (FDA) top medical device regulator, calling on the agency to provide for public access information about medical devices cleared through FDA's 510(k) premarket notification process. The letter , sent 15 August by Rep. Edward Markey (D-MA) and Sen. Jeff Merkley (D-OR), observes that several medical devices once cleared through the 510(k) process have been subject to high-profile safety concerns and rec...
  • Report: Monitoring Scandal Involves Top FDA Officials

    Top officials in the US Food and Drug Administration (FDA) were personally involved in reviewing and approving a surveillance program which targeted group of whistleblowers within the agency, reports The Wall Street Journal . The Journal's 7 August report highlights for the first time the involvement of FDA Commissioner Margaret Hamburg, the top official at the US regulatory agency, who was reportedly briefed on the surveillance program shortly after the initiat...
  • Investigation into FDA Reveals 'Enemies List,' Extensive Monitoring Practices

    An investigation into the US Food and Drug Administration (FDA) by The New York Times has revealed the agency established an extensive monitoring program aimed at both restricting leaks of confidential information and establishing what The Times refers to as "an enemies list of sorts." The agency is currently under investigation--and is being sued by--various groups who allege the agency spied on its own employees, violating both whistleblower protection laws and v...
  • Report: Internal FDA Report Slams European Regulation of Medical Devices as Ineffective

    The US Food and Drug Administration (FDA) has lambasted Europe's review process for medical devices in an unreleased internal report, claiming the failure of some devices to obtain FDA approval despite being approved in Europe is an "affirmation of the US medical device approval process," reports The Star Tribune . "The strongly worded document details what the FDA says are 12 classes of malfunctioning or needlessly invasive high-risk medical devices approved for sale i...
  • Drafts of PDUFA, MDUFA Released in House, Senate

    Congressional committees responsible for the oversight of the US Food and Drug Administration (FDA) released discussion drafts intended to start the debate over the reauthorization of the Prescription Drug User Fee Act (PDUFA) . The Senate Health, Education, Labor and Pensions (HELP) Committee's discussion draft, The Food and Drug Administration Safety and Innovation Act (FDASI) , comes before a 25 April hearing to reauthorize PDUFA , the Medical Device User Fe...
  • FDA Opens Innovation Pathway to First Round of Devices

    The US Food and Drug Administration (FDA) is announcing its intention to open up its experimental Innovation Pathway to three medical device companies developing therapies for end stage renal disease (ESRD). FDA's 9 April announcement said the three organizations-CreatiVasc Medical, Blood Purification Technologies Inc. and the University of California-were among 32 product applications covering a wide range of applications.  "The response from innovators exceeded...
  • Shuren's Senate Testimony Yields Wealth of Insight

    The US Food and Drug Administration's (FDA) top device regulator, Jeffery Shuren, director of the Center for Devices and Radiological Health (CDRH), testified before the Senate Health, Education, Labor and Pensions Committee yesterday (29 March), providing a wealth of information on CDRH, the medical device review process and agency performance. Shuren's testimony also yielded a wealth of other information of interest to regulatory professionals, including: FDA request...