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  • Regulatory NewsRegulatory News

    Eudamed to Launch in 2022 for Both Devices and IVDs

    The European Commission recently concluded that its database of medical device information (Eudamed) will only be operational once all modules are fully functional and an independent audit has been conducted, so the commission has decided to launch the database simultaneously for both medical devices and in-vitro diagnostics together in May 2022. The two-year delay of the database for medical devices (the commission reiterated that date of application of the Medical Dev...
  • Regulatory NewsRegulatory News

    OIG Report on FDA’s Postmarket Surveillance of Devices Coming in 2020

    The US Department of Health and Human Services’ Office of Inspector General (OIG) will issue a report next year on the US Food and Drug Administration’s (FDA) postmarket surveillance of medical devices, which has come under fire in recent months. OIG says it will assess and describe how FDA's “established passive postmarket surveillance system” identifies and tracks safety concerns and responds to them. “We will also describe how elements of FDA's newer surveillance ...
  • Regulatory NewsRegulatory News

    2020 Guidance: CDRH Offers a Look at What’s Coming

    FDA’s Center for Devices and Radiological Health (CDRH) on Friday released its FY 2020 draft and final guidance list, which features a few repeats from last year and new drafts coming on device servicing and remanufacturing, unique device identification and patient-reported outcome measures used in device submissions, among others. As in years past, CDRH divides the list between “A-list” draft and final guidances, which are a priority, and a smaller “B-list” of draft an...
  • RoundupsRoundups

    Asia Regulatory Roundup: India to Add EU to List of Regions Covered by Clinical Trial Waiver

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   India Seeks Feedback on Mandatory use of QR Codes on API Packaging   India is planning to require manufacturers to feature quick response (QR) codes on the packaging of locally made and imported active pharmaceutical ingredients (API). The Indian government plans to implement the system at the start of April.   Through an amendment to the Drugs and Cosmetics Rule...
  • Regulatory NewsRegulatory News

    FDA Finalizes Guidance on Convenience Kit UDI Marking

    The US Food and Drug Administration (FDA) issued final guidance Thursday to provide medical device manufacturers clarifications on unique device identification (UDI) marking policies for convenience kits. The guidance finalized the 2016 draft version of the document, developed by FDA’s Center for Devices and Radiological Health and its Center for Biologics Evaluation and Research. Combination products and in vitro diagnostics subject to labeling requirements fall ou...
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    WHO Advances International Harmonized Nomenclature for Medical Devices

    The World Health Organization (WHO) reported Monday on recent progress toward the development of its international nomenclature for medical devices, known as the International Classification of Medical Devices (ICMD). WHO discussed work in progress at the 4th Global Forum on Medical Devices, which took place last December. “Having a nomenclature system in place for medical devices facilitates their management and regulation by standardizing terms that enable communic...
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    US, EU Pledge to Cooperate on UDI Specifications

    The US and EU will cooperate to ensure alignment of electronic database specifications for Unique Device Identifiers (UDIs) and will develop a bilateral test of compatibility of respective UDI databases, according to the interim report on the work of the US-EU Executive Working Group (EWG) on trade. The report said such cooperative work will be in concert with ongoing efforts from the International Medical Device Regulators Forum (IMDRF), which consulted on UDIs in 20...
  • Regulatory NewsRegulatory News

    FDA Flags Violations at Medical Device Firms in Sweden, Canada, Spain, UK

    Device firms in Sweden, Canada, Spain and the UK separately drew four US Food and Drug Administration (FDA) warning letters over good manufacturing practice (GMP) violations.   The GMP violations cited in the warning letters posted Tuesday stem from inspectional observations first noted in FDA Form 483s issued to each of the four device manufacturing facilities, following the site visits investigators conducted during 2017 and 2018.   Most of the firms issued res...
  • Regulatory NewsRegulatory News

    First Version of NEST to Launch in 2019

    The National Evaluation System for health Technology (NEST) will become increasingly crucial for tracking medical devices at FDA’s Center for Devices and Radiological Health (CDRH), though its creation continues to be fraught with limitations. The timeline for an initial version of the NEST Coordinating Center (NESTcc) is tight, Rachel Fleurence, NESTcc executive director, noted Wednesday at the MDEpiNet annual meeting at FDA’s White Oak campus. The idea for NEST origina...
  • Regulatory NewsRegulatory News

    CDRH Looks Ahead to Priorities for 2018 to 2022

    The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) announced Wednesday that it has met its three strategic goals from 2016 and 2017 and it has outlined three more for 2018 to 2022. Looking ahead to these next three years, CDRH Director Jeff Shuren pointed to three priorities: Better engage the center’s employees and decrease turnover rates, streamline and modernize at least 80% of the center’s processes, and establish new ...
  • Regulatory NewsRegulatory News

    FDA Pushes Back Enforcement of UDI Requirements for Class I, Unclassified Devices

    The US Food and Drug Administration (FDA) said Friday that it will delay its enforcement of certain unique device identification (UDI) system requirements for class I and unclassified devices by two years. A Federal Register notice on guidance released Friday, which FDA said takes effect immediately, said: "FDA does not intend to enforce standard date formatting, labeling, and Global Unique Device Identification Database (GUDID) data submission requirements under Ag...
  • 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...