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  • Regulatory NewsRegulatory News

    FDA Pilot to Sign Off on Low-Risk Digital Health Products Without Premarket Review

    US Food and Drug Administration (FDA) Commissioner Scott Gottlieb on Thursday announced an upcoming pilot program that would create a third-party certification program under which lower-risk digital health products could be marketed without FDA premarket review and higher-risk products could be marketed with a streamlined FDA review. The pilot, part of a new approach to regulating digital health tools, would help to certify, according to Gottlieb, whether a company ...
  • RAPS' LatestRAPS' Latest

    6 Things You Need to Do to Prepare for the New EU Medical Devices Regulation

    When the EU’s new Medical Devices Regulation ( MDR ) entered into force last month, it set in motion a three-year countdown to the new rules’ full application in 2020. For companies marketing devices in the EU that wish to continue to do so, there is a lot to do in that relatively short time, so it is critical to begin as soon as possible. Early preparation is key. Following are six things you should be doing to get ready. 1. Plan Ahead In order to figure out wh...
  • Regulatory NewsRegulatory News

    FDA Amends Humanitarian Device Exemption Regulations

    The US Food and Drug Administration (FDA) on Tuesday announced that it is amending its regulations governing humanitarian device exemptions (HDE) to reflect changes brought on by the 21st Century Cures Act . These exemptions provide a pathway for device makers looking to develop medical devices for small patient populations by exempting them from demonstrating a device's effectiveness. Instead, a company must demonstrate that the humanitarian use device (HUD) "will no...
  • Regulatory NewsRegulatory News

    FDA Delays UDI Requirements for Low-Risk Devices

    The US Food and Drug Administration (FDA) on Friday notified medical device labelers that it is extending the compliance dates for certain unique device identifier (UDI) requirements for Class I and unclassified devices. Rollout of FDA's UDI rule has been fraught with challenges. Since issuing the final UDI rule in 2013, FDA has pushed back compliance dates for a number of devices in response to concerns from companies over meeting deadlines or to address specific t...
  • Feature ArticlesFeature Articles

    Navigating the Medical Device User Fee Act (MDUFA)

    This article examines the benefits for both FDA and the medical device industry derived from "user fees" authorized by the passage of the Medical Device User Fee Act (MDUFA 2002) and its subsequent reauthorizations. 1 Introduction The category "medical devices" encompasses a wide variety of products intended for diagnosing diseases or other conditions as well as the cure, mitigation, treatment or prevention of disease. 2 Among its responsibilities, the US Food and D...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: CFDA Seeks to Exempt More Devices From Clinical Trials (23 May 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. Abbott, Novartis and Sanofi Targeted in NPPA Clampdown on Drugs Sold Without Price Approval The National Pharmaceutical Pricing Authority (NPPA) of India is taking action against drugmakers including Abbott, GlaxoSmithKline, Novartis and Sanofi. NPPA included the top pharmaceutical firms on a list of companies that allegedly introduced drugs without seeking price appro...
  • RAPS' LatestRAPS' Latest

    RAPS and Industry Experts Join Forces for Dedicated MDR Workshop

    • 18 May 2017
    RAPS is bringing together a panel of Europe’s top industry experts to deliver a dedicated workshop on the new EU regulations for medical devices and in vitro diagnostic devices. ‘ EU Regulatory Essentials, Medical Device and In Vitro Diagnostics: Transitioning from Current Directives to New Regulations ’ will take place on 4 and 5 July in Brussels and will introduce and explain the new EU regulations. Offered for the first time in Europe, the workshop will also...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: CFDA Offers New Drug, Device Draft Guidance (16 May 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. China Shares Flurry of Proposals to Encourage Drug, Medical Device Innovation The China Food and Drug Administration (CFDA) has released four draft documents intended to encourage innovation in the drug and medical device industries. CFDA’s proposals aim to cut the time it takes to set up a clinical study, accelerate the approval process, overhaul the patent system and...
  • Regulatory NewsRegulatory News

    FDA Signs Off on New Device to Treat Esophageal Birth Defect in Babies

    The US Food and Drug Administration (FDA) on Friday authorized the use of a first-of-its-kind medical device to treat infants up to one year old for a rare birth defect that causes a gap in the esophagus. The device, Cook Medical’s Flourish Pediatric Esophageal Atresia Anastomosis, was authorized via the humanitarian device exemption (HDE) process as an estimated 1 in every 2,500 babies in the US is born with the condition, known as esophageal atresia. "This new...
  • Regulatory NewsRegulatory News

    FDA Warns Lonza’s Class II Device Manufacturing Site

    The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent 21 April to Lonza’s contract manufacturing site for Class II devices in Walkersville, MD. The four observations from the inspection conducted from 18 January 2017 through 6 February 2017 deal with validation failures, the site’s failure to develop, conduct, control and monitor production processes, corrective and preventive action (CAPA) failures and a failure to adequately establis...
  • Regulatory NewsRegulatory News

    Final EU MDR, IVDR Texts Published, Countdown to Implementation Begins

    The final texts of the new European medical device and in vitro diagnostic (IVD) regulations were published on Friday in the Official Journal of the European Union , setting in motion the timeline for implementation of the new regulations to commence on 25 May. Gert Bos, executive director at Qserve Group and a RAPS board member, explained to attendees of the MedCon conference in Cincinnati on Thursday some of the difficulties that industries will face over the ...
  • Regulatory NewsRegulatory News

    FDA to Create Digital Health Unit

    With ongoing work on guidance related to software as a medical device, and a new dedicated unit to digital health coming to the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH), the agency is slowly but surely dipping its toe into the rapidly advancing field. Bakul Patel, ‎associate center director for digital health at FDA, told attendees at MedCon in Cincinnati on Thursday that current work is directed at funneling through abou...