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  • 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

    Q&A: Why Seven Regulators Use One Company’s Software for Drug and Biologics Reviews

    To streamline decision-making in approval processes, three regulatory authorities joined four others Thursday in increasing their adoption of drug development consultancy Certara’s Phoenix platform. The UK’s Medicines and Healthcare products Agency (MHRA), Brazil’s National Health Surveillance Agency (ANVISA) and Japan’s Pharmaceuticals and Medical Device Agency (PMDA) are now licensing Certara’s Phoenix IVIVC toolkit for in vitro-in vivo correlation. The agencies wer...
  • Regulatory NewsRegulatory News

    FDA’s De Novo Program Gains Momentum

    The US Food and Drug Administration (FDA) has been steadily increasing the annual number of granted de novo classification requests in recent years and hit a record of 44 de novos granted during 2018. The de novo premarket review pathway, used for novel, low-to-moderate-risk devices that are not substantially equivalent to already marketed devices, has increasingly attracted interest in the medical device ecosystem, particularly after the quick turnaround for Apple’s g...
  • Regulatory NewsRegulatory News

    510(k) Modernization: FDA Floats Need to Pursue New Authority

    Plans at the US Food and Drug Administration (FDA) to “modernize” the most commonly used pathway for new medical device clearances “might require new authority,” FDA leadership said on Monday. FDA Commissioner Scott Gottlieb and Jeff Shuren, director of FDA’s Center for Devices and Radiological Health (CDRH), issued a joint statement to announce 2018 progress on novel device approvals, pointing out that the breakthrough 510(k) is one of two submission types that was new...
  • Regulatory NewsRegulatory News

    CDRH Outlines Next Steps to Implement New Safety and Performance Based Pathway

    Following Tuesday’s final guidance that established a new option for 510(k) clearance, a spokesperson from the Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration (FDA) highlighted next steps to implement the new Safety and Performance Based Pathway in 2019. “Our next step is to develop an implementation plan to apply this Safety and Performance Based Pathway,” CDRH spokesperson Angela Stark told Focus . “We encourage industry and o...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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 ...
  • Regulatory NewsRegulatory News

    FDA Seeks to Overhaul 510(k) Program in Push for Modern Performance Standards

    While seeking to safeguard its gold standard for approvals, the US Food and Drug Administration (FDA) is modernizing its 510(k) regulatory review pathway, with more of a focus on predicate medical devices that are 10 years old or less. “We believe that where appropriate, new medical devices that come to market under the 510(k) pathway should either account for advances in technology or demonstrate that they meet more modern safety and performance criteria,” FDA Commissi...
  • Feature ArticlesFeature Articles

    Surviving Your First FSMA Inspection

    This article provides an overview of the new FSMA regulations and suggests some recommended steps to prepare for inspections, including preventive controls, supply chain management and good record keeping practices. Introduction Without question, the US Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA) is the most significant food safety law of our generation. The original Federal Food, Drug, and Cosmetic Act of 1938, included a single sentence ...
  • Report: Future of FDA's $280 Million IT Improvement Program 'Uncertain'

    A report issued by the Government Accountability Office (GAO) has found the US Food and Drug Administration's (FDA) information technology (IT) infrastructure improvement project-a $280 million program known as the Mission Accomplishments and Regulatory Compliance Services (MARCS) program-is suffering from a cavalcade of operational deficiencies and may not be completed. The program "is intended to enhance existing applications and develop new systems that provide infor...
  • Updated List of Recognized Medical Device Standards Released By FDA

    The US Food and Drug Administration (FDA) published an updated list of FDA-recognized medical device standards, aiming to "assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices." Under the 1997 Food and Drug Administration Modernization Act (FDAMA) , FDA is authorized to recognize consensus standards developed by national and international organizations. The list was last updated in August 2011, an...
  • Congress Slams Third-party Food Facility Audits

    A congressional report released on 10 January slammed a third-party auditor for giving a food production facility a "superior" ranking just two months before an outbreak of listeria that originated at the facility killed 30 people . The facility, Jensen Farms, had hired Colorado-based Primus Labs to conduct the facility's audit. Congressional investigators found that the auditors were either ignorant of FDA guidance documents regarding food safety or blatantly ...