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  • Regulatory NewsRegulatory News

    FDA Releases Guidance on Software as a Medical Device for Consultation

    The US Food and Drug Administration (FDA) on Thursday opened a public consultation on a harmonized guidance on the clinical evaluation of software as a medical device (SaMD) developed by the International Medical Device Regulators Forum (IMDRF). Proposed Guidance According to IMDRF, the goal of the guidance is "to establish a common and converged understanding of clinical evaluation and principles for demonstrating the safety, effectiveness and performance of [SaMD]." ...
  • Regulatory NewsRegulatory News

    510(k) Third Party Review Program: FDA Offers New Draft Guidance

    The US Food and Drug Administration (FDA) on Friday issued new draft guidance updating the agency’s current thinking on a program used to accredit third parties to review premarket notification (510(k)) submissions for medical devices and recommend the initial classification of certain devices. In an effort to encourage harmonization, the guidance refers to standards described in the International Medical Device Regulators Forum (IMDRF) documents as criteria FDA will con...
  • Regulatory NewsRegulatory News

    Cash-Strapped MHRA Looks to Stay Flexible

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday released its business plan for 2016-17, warning of serious financial troubles, particularly as funding for the regulation of medical devices has declined over the past decade and as it's losing revenue from industry because of changes at the EU level. “Funding for devices regulation is at half the level of what it was in 2003 in real terms; and while a number of efficiency measures have been t...
  • Regulatory NewsRegulatory News

    IMDRF Offers Progress Updates at March Meeting

    The ninth meeting of the management committee of the International Medical Device Regulators Forum (IMDRF) took place in Brasília, Brazil, from 8 to 10 March 2016 and included high-level updates on how the group’s seven current work items are progressing and how device regulations are continuing to converge at the international level. Background Originally launched as the Global Harmonization Task Force (GHTF) in 2012, the IMDRF is composed of regulators from Australia,...
  • Feature ArticlesFeature Articles

    Practical Guidance for Regulatory Professionals on Combination Products

    This article provides an overview of combination products and practical suggestions and strategies for regulatory affairs professionals when developing global submission strategies and contributing to development and design control activities. Combination Products Combining a drug, device or biological product into a new product (frequently called a "combination product") continues to be an important and growing category of therapeutic products. Approximately one-thir...
  • Regulatory NewsRegulatory News

    IMDRF Sets New Long-Term Priorities on Pre-Market Review, Post-Market Surveillance of Devices

    The International Medical Device Regulators Forum (IMDRF) says its focus over the next four years will be to hone in on the convergence of regulations across jurisdictions, and in supporting innovation and timely access to safe and effective medical devices, according to a strategic plan unveiled earlier this month. The forum's management committee has also identified two new areas where it plans to focus its work: enhancing post-market surveillance and improving the eff...
  • Regulatory NewsRegulatory News

    Medical Device Audit Program Needs More Industry Involvement, Report Says

    A mid-pilot report on the international Medical Device Single Audit Program shows some progress, though work still needs to be done, particularly in terms of attracting industry participants before the expected operational launch in 2017, a recent report says. Background Back in January 2014, the International Medical Device Regulators Forum (IMDRF), the regulators-only successor group to the Global Harmonization Task Force, launched a two-year pilot program ...
  • Regulatory NewsRegulatory News

    IMDRF Participants Outline Plans for Next Week’s Meeting in Japan

    In anticipation of the International Medical Device Regulators Forum (IMDRF) stakeholders meeting in Japan next week, participating countries’ regulators, trade groups and others have outlined a number of updates they plan to share. Background Begun in 2011, IMDRF is a voluntary group of medical device regulators from Australia, Brazil, Canada, China, EU, Japan and the US, as well as the World Health Organization (WHO), with the aim of accelerating international medical...
  • Regulatory NewsRegulatory News

    Brazilian Regulators Propose Amendments to Country's Clinical Trial Rules

    This content is provided by RegLink News , publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members. Brazil’s national regulatory agency, Anvisa, announced on 4 August 2014 that it has opened consultations on two separate proposed regulations that would amend existing procedures governing clinical trials with both drugs and medical devices. The first, CP 64, targets medica...