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  • Regulatory NewsRegulatory News

    FDA Modifies List of Standards for Premarket Device Reviews

    The modified list of standards published on Wednesday is meant to assist medical device manufacturers that elect to declare conformity with consensus standards to meet certain US Food and Drug Administration (FDA) requirements. Back in 1997, the Food and Drug Administration Modernization Act allowed FDA to recognize consensus standards developed by national and international organizations to satisfy certain portions of device premarket review submissions or other requ...
  • Regulatory NewsRegulatory News

    New Report Compares FDA Quality System Requirements With ISO 13485:2016

    The Association for the Advancement of Medical Instrumentation (AAMI) this week released a technical information report to help the medical device industry prepare for the revision of 21 CFR 820 (also known as the quality system regulation), which will harmonize with ISO 13485:2016 later this year. The most recent regulatory agenda says that sometime this month the US Food and Drug Administration (FDA) will issue a proposed rulemaking on the harmonization and moderniz...
  • Regulatory NewsRegulatory News

    Experts Tell Device Companies Not to Fret Over QMS Transition

    Ahead of the proposed shift away from the current US Food and Drug Administration (FDA) quality management system (QMS) CFR 21 Part 820 regulation toward ISO 13485:2016, a new white paper sheds light on how the action will impact medical device development. The white paper identified three interrelated principles that will define the direction of the agency’s process, which has yet to be clearly defined, after the transition . These principles relate to the concept of ...
  • Regulatory NewsRegulatory News

    ISO: Identification of Medicinal Products Standards Revised

    The International Organization for Standardization (ISO) is revising a series of standards known as Identification of Medicinal Products (IDMP) standards as part of an effort to simplify the exchange of medicinal product information. "When regulators adopt IDMP, their capacity to interoperate with each other makes for safer patient care; this is, for example, a huge benefit for adverse-event reporting and for documenting medication in patient records," Christian Hay...
  • Feature ArticlesFeature Articles

    Identification of Medicinal Products (IDMP) Standards Part 4: Technical Approaches to IDMP

    This article discusses IT approaches to support a gap analysis and implementation of the upcoming Identification of Medicinal Products (IDMP) standards with regard to generating, collecting and mapping accurate and correct data prior to submission in an effort to prevent delays in a product reaching the market. This is the final installment in a four-part series on the IDMP standards and their respective implementation guidelines. 1-10 The first three articles explained...
  • Feature ArticlesFeature Articles

    Identification of Medicinal Products (IDMP) Standards Part 2: The Implementation Roadmap

    This is part two of a series on the Identification of Medicinal Products (IDMP) standards and their respective implementation guidelines. 1-9 Part two reports on current IDMP activities and provides the plans and timelines in the IDMP implementation process. Part one 10 presented the reasons for the new standard, the driving forces behind IDMP and the concepts behind the standard. Current Status of ISO Activities A new version of the International Organization for...
  • Feature ArticlesFeature Articles

    Identification of Medicinal Products (IDMP) Standards Part 1: Impact on the Regulatory World

    This is part one of a four-part series on the Identification of Medicinal Products (IDMP) standards and their respective implementation guidelines. 1-9 This segment reviews the steps needed to prepare for their global implementation and offers technical solution options for the industry. Why IDMP? Despite clear progress in the development of increasingly specific and complex drugs, health authorities worldwide say they have observed a steady and alarming increase in ...
  • Regulatory NewsRegulatory News

    How Will ISO 13485:2016 Impact Your Relationship With Suppliers?

    • 22 November 2016
    This article covers how the new ISO 13485 standard 1 affects risk management for suppliers. The 2016 revision to ISO 13485 may have profound implications for the medical device industry. The updated standard will alter the way device makers interact with suppliers, from supplier selection to the management of supplier relationships. What the new Standard Says About Risk One particularly notable change with ISO 13485:2016 2 is the addition of more explicit ris...
  • Feature ArticlesFeature Articles

    How Will ISO 13485:2016 Impact Your Relationship With Suppliers?

    This article covers how the new ISO 13485 standard 1 affects risk management for suppliers. The 2016 revision to ISO 13485 may have profound implications for the medical device industry. The updated standard will alter the way device makers interact with suppliers, from supplier selection to the management of supplier relationships. What the new Standard Says About Risk One particularly notable change with ISO 13485:2016 2 is the addition of more explicit ris...
  • Regulatory NewsRegulatory News

    ISO 13485: Ex-FDA Official Kim Trautman Gives Advice on Transitioning

    Speaking at RAPS' 2016 Regulatory Convergence, leading medical device quality systems expert and former FDA official, Kim Trautman, urged attendees to begin their transition to the recently released ISO 13485:2016 as soon as possible. Trautman, who left her position as associate director for international affairs at FDA's Center for Devices and Radiological Health (CDRH) for a position at NSF International earlier this year, was instrumental in writing FDA's 1996 Quality...
  • Regulatory NewsRegulatory News

    European Commission Publishes New Harmonized Standards for Devices, Implants, IVDs

    In the Official Journal of the European Union, the European Commission on Friday published a new list of the harmonized standards that manufacturers of medical devices, implantable devices and in vitro diagnostic devices can use to demonstrate their products comply with EU law. The standards were published as part of the implementation of the European Council’s Directive 93/42/EEC from 1993, which deals with medical devices and their regulation. Background ...
  • Feature ArticlesFeature Articles

    ISO IDMP: Another Compliance Project or a new way of Conducting Business?

    This article discusses Identification of Medicinal Products (IDMP) as a new way of conducting business, the benefits gained by adopting the IDMP model and how IDMP can be implemented to help businesses run more efficiently. To support the continuous improvement of pharmacovigilance oversight within the EU, the European Commission (2012) has mandated pharmaceutical companies to submit product information according to ISO IDMP standards. 1 The standards are global and o...