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  • Regulatory NewsRegulatory News

    CDRH Fleshes Out Guidance on Application of Least Burdensome Provisions

    The US Food and Drug Administration (FDA) on Monday published final guidance on the FD&C Act’s least burdensome provisions for the regulation of medical devices, highlighting recent initiatives via newly added themes. The 24-page document, which finalizes a draft from December 2017, is intended to reflect guiding principles that require “the minimum amount of information necessary to adequately address a relevant regulatory question or issue through the most efficient...
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    Health Canada Seeks to Better Define Regulatory Requirements for SaMD

    Health Canada released a draft guidance document on Tuesday to aid industry in determining whether the agency intends to regulate a software product as software as a medical device (SaMD). Health Canada notified industry last year of its intent to release draft guidance on SaMD as part of a larger initiative to improve regulatory reviews. The timeline, however, was delayed after a Health Canada scientific advisory panel raised concerns over the previous approach, whic...
  • Regulatory NewsRegulatory News

    Canada Completes Transition to MDSAP

    Most companies in the Canada market were able to meet the 1 January deadline to complete the transition into the Medical Device Single Audit Program (MDSAP), according to Canada’s MEDEC. "We have been flooded with transition packages and we're going through all of them," Ian Sullivan, regulatory affairs specialist at Health Canada' Medical Devices Bureau, told Focus . The stack of transition packages has taken priority over calculating the final statistics on exact...
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    TGA Pushes for Total Product Lifecycle Approach to Medical Device Cybersecurity

    New draft guidance from Australia’s Therapeutic Goods Administration (TGA) encouraged use of regulatory policies that span total product lifecycles (TPLC) to ensure medical device cybersecurity. A “growing area of interest” for TGA relates to “a large number” of class II, class III and active implantable devices registered in Australia that contain “electronic components with embedded software, have a software accessory or are a software device,” the regulator noted in ...
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    US Regulatory Landscape for Medical Devices: A Year in Review and a Look Ahead

    From a transition to the global standard for quality management systems (QMS) to the revamping of premarket review pathways in the US, the medical device industry can expect to see at least some regulatory initiatives that 2018 set in motion come to fruition in 2019.   The Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration (FDA) has released  its list of guidances, indicating which topics will take precedence for 2019 policy cla...
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    Premarket Device Cybersecurity: Health Canada Issues Draft Guidance

     Health Canada posted a new draft guidance document on Friday to aid medical device manufacturers in complying with premarket cybersecurity requirements.   The move comes as more regulators seek to expand on considerations for the cybersecurity of medical devices as the health care sector became a prime target for cyberattacks amid an increasingly connected ecosystem.   The US Food and Drug Administration (FDA) issued premarket draft guidance for medical devices ...
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    Experts Question Impact on Innovation, FDA Authority to Pursue Revamp of 510(k) Pathway

    Following Monday’s announcement from the US Food and Drug Administration (FDA) on its plans to remodel one of the review pathways for medical devices, industry trade associations pushed back on certain parts of the proposal that may hinder innovation. AdvaMed and the Medical Device Manufacturer Association (MDMA), among others, expressed mixed reactions to FDA’s policy proposals for modernization of the decades-old 510(k) framework. The device groups agreed with FDA ...
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    Health Canada Drafts Policies on 3D-Printed Implantable Devices

    Health Canada released draft guidance Thursday to aid manufacturers in preparing license applications for implantable medical devices produced by additive manufacturing or 3D-printing.   The guidance “represents the first phase of 3D-printing policy in Canada” because Health Canada intends to continuously adapt its policies to emerging issues on the topic “due to the fast-changing technological environment,” the regulator said.   3D-printed medical devices may be s...
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    Insights on Upcoming Revisions to ISO 13485

    Following the new outcome meeting statement posted Monday by the management committee of the International Medical Device Regulators Forum (IMDRF), Focus obtained insights into upcoming revisions to the global standard for quality management systems (QMS), ISO 13485.   The outcome statement from the September IMDRF meeting in Beijing, China points to a decision made by the management committee to issue a position statement to the International Organization for Standa...
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    Health Canada: MDSAP Could Force Some Manufacturers Out

    With the approaching deadline for those in Canada to comply with the Medical Device Single Audit Program (MDSAP), Health Canada issued a notice to recognize that some device makers may be cancelling their licenses to avoid dealing with the new requirements. “It is anticipated that some manufacturers, instead of conforming to the new MDSAP requirements, may be cancelling their medical device licences and discontinuing the sale of their products as early as November 1, 201...
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    IMDRF Offers New Guideline on Adverse Event Reporting

    As a way to improve the accuracy and capture of medical device adverse events, the International Medical Device Regulators Forum (IMDRF), a voluntary and global group of device regulators, on Monday published a new final guideline on a harmonized terminology for reporting such events. "Widespread use of a single, appropriate adverse event terminology and coding system is expected to improve signal detection by adverse event management systems enabling a faster response ...
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    IMDRF Offers a Preview of Next Week’s Vancouver Meeting

    Members of the International Medical Device Regulators Forum (IMDRF) will meet next week in Vancouver for the group’s 11th meeting. Presentations on updates from members located in the US, EU, Brazil, Australia, as well as updates on IMDRF working groups were unveiled recently. For the EU’s latest update, Erik Hansson from the European Commission will discuss the new regulations for medical devices and in vitro diagnostics (IVDs). Voting on the texts is expected thi...