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  • Regulatory NewsRegulatory News

    FDA Seeks to Overhaul 510(k) Program in Push for Modern Performance Standards

    While seeking to safeguard its gold standard for approvals, the US Food and Drug Administration (FDA) is modernizing its 510(k) regulatory review pathway, with more of a focus on predicate medical devices that are 10 years old or less. “We believe that where appropriate, new medical devices that come to market under the 510(k) pathway should either account for advances in technology or demonstrate that they meet more modern safety and performance criteria,” FDA Commissi...
  • Regulatory NewsRegulatory News

    Medical Device Safety Action Plan: FDA Sets Measure of Success Amid Funding Issues

    The US Food and Drug Administration (FDA) updated its medical device safety action plan on Tuesday with “an important and ambitious new goal” and explained the path forward for its planned nationwide device surveillance system.   The new goal to propel the safety action plan— released in April—is centered around ensuring that the agency is “consistently first among the world’s regulatory agencies to identify and act upon safety signals related to medical devices,” FDA...
  • Regulatory NewsRegulatory News

    Barriers to FDA and CMS Parallel Reviews: Fear and Bandwidth, Shuren Says

    Medical device companies should want to streamline the process of getting their products reviewed simultaneously by the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) and Centers for Medicare and Medicaid Services (CMS) - so why aren’t they? Jeff Shuren, director of CDRH late Monday told attendees of JP Morgan’s annual conference that he thinks fear and a limited amount of CMS staff are two reasons that the parallel review ...
  • Regulatory NewsRegulatory News

    Building NEST: New Executive Director, CDRH's Shuren Discuss Plans

    The group of stakeholders building the National Evaluation System for health Technology (NEST) outlined what’s in store for the new future as well as the direction that they want the system to go. "NEST is about how we improve the value, use, and time and cost of using real-world data," Jeff Shuren, director of the US Food and Drug Administration’s (FDA) Center for Device and Radiological Health (CDRH), explained to attendees of AdvaMed’s MedTech conference in San J...
  • Regulatory NewsRegulatory News

    FDA Office of Regulatory Affairs Realignment to Begin in May

    The US Food and Drug Administration's (FDA) Office of Regulatory Affairs (ORA), which carries out the agency's inspection program, will officially begin a major overhaul in the coming weeks, according to FDA's Center for Devices and Radiological Health (CDRH) Director Jeffrey Shuren. Shuren made the announcement to members of the House Energy & Commerce Committee on Tuesday at a hearing on the Medical Device User Fee Amendments , which must be reauthorized by 30 Septemb...
  • Regulatory NewsRegulatory News

    As FDA Tries to Regulate Lab-Developed Tests, Congress Signals Potential Opposition

    Last month, the US Food and Drug Administration (FDA) announced it would soon seek to regulate lab-developed tests more similarly to in vitro diagnostics (IVDs), citing the devices' increasing complexity and role in critical clinical decision-making. And while the plan has received some pushback from legal groups , including the Washington Legal Foundation, it might soon have another, more prominent opponent: Members of Congress. Background LDTs are, as their name imp...
  • CDRH Whistleblowing Scandal Back in Spotlight as Congress Again Takes Interest

    If US Food and Drug Administration (FDA) officials thought they had finally moved past a scandal that has embroiled the agency's medical device division for years, they apparently thought wrong. This piece has been updated with comment from FDA. See the FDA Comments' section . -Ed. Background On 26 February 2013, the US House Oversight Committee is set to re-examine a 2012 scandal involving FDA's Center for Devices and Radiological Health (CDRH) in which the agency ...
  • Mobile App Regulation Focus of Upcoming Legislative Hearing

    US legislators are preparing to once again examine the US Food and Drug Administration's (FDA) approach to the regulation of mobile medical applications, this time focusing on its recently released final guidance document which calls for a risk-based approach. Background Under the  Federal Food, Drug and Cosmetic Act (FD&C Act) , medical devices are defined as being any "instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent...
  • House Legislators Set to Grill FDA on FDASIA Progress

    It's been more than a year since legislators passed the Food and Drug Administration Safety and Innovation Act (FDASIA) into law, and now those same legislators want to know: How is the law doing? Background: FDASIA's User Fee Provisions FDASIA , passed in July 2012, contains provisions that can generally be lumped into two broad categories: user fee programs and reforms. To the former (Titles I-IV), FDASIA reauthorized two major user fee programs, the Prescripti...
  • Hamburg, Shuren Say CDRH Set to Meet MDUFA Goals This Year

    Several high-ranking officials with the US Food and Drug Administration (FDA) expressed confidence this week that they will meet all their obligations to industry under the medical device provisions of the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012. Hamburg and Shuren: CDRH on Track Speaking in Washington, DC at the Advamed conference on 25 September 2013, FDA commissioner Margaret Hamburg provided extensive remarks on the requirements and...
  • 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...