• Regulatory NewsRegulatory News

    FDA outlines safety and performance-based criteria for facet screw systems and denture base resins

    The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Monday issued two draft guidances outlining the performance criteria and testing methodologies device makers can use to support 510(k) submissions for denture-based resins and facet screw systems under the agency’s safety and performance-based pathway.   FDA issued final guidance in September 2019 explaining the new safety and performance-based pathway, which allows device ...
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    COVID-19: FDA offers guidance on container closure switches

    The COVID-19 pandemic has created unprecedented global demand for raw materials and components of products used in the response to the virus. Supply chains for critical materials such as reagents, test swabs and now the glass vials and stoppers used to hold vaccines and therapeutics have been impacted, necessitating workarounds to keep pace with demand.   With COVID-19 vaccines and several therapeutics using glass vials and stoppers for their container closure systems ...
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    FDA Issues Draft Q&A on Electronic Systems in Clinical Investigations

    The US Food and Drug Administration (FDA) on Tuesday issued a draft questions and answers guidance to clarify expectations for using electronic systems, including electronic records, cloud computing and mobile technology, in clinical investigations. Specifically, the guidance provides 28 questions and answers detailing how drugmakers, clinical investigators, clinical research organizations (CROs) and institutional review boards (IRBs) can ensure such electronic systems m...
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    How to Mitigate Cross-Contamination During Colonoscopies, Final FDA Guidance Explains

    During a colonoscopy or esophagogastroduodenoscopy (EGD), clinicians often use an irrigation system but typically do not clean and sterilize all components of the system after each procedure, so the US Food and Drug Administration (FDA) on Tuesday issued guidance highlighting the risks of cross-contamination posed by specific practices and types of irrigation valves and accessories. The 12-page guidance, first proposed in January 2015, notes that the risk of cross-conta...
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    FDA Finalizes Two Guidance Documents on Blood Glucose Monitoring Systems

    • 07 October 2016
    The Food and Drug Administration (FDA) on Friday finalized two guidance documents related to blood glucose monitoring systems (BGMSs), offering new recommendations on the different types of information in 510(k)s for BGMSs used by health professionals versus SMBGs intended for home use by lay users. FDA says the guidance was necessary as it has become increasingly clear that these different use settings have distinct intended use populations with unique characteristics...
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    Health Canada Finalizes IVD Labeling Guidance After 18 Years

    The Canadian regulatory agency Health Canada on Friday finalized its guidance for labeling in vitro diagnostic (IVD) devices nearly 18 years after releasing the draft version in 1998. The final guidance includes new considerations for electronic labeling, IVDs with small containers, blood glucose monitors and information on complying with Canada's Official Languages Act , which requires product labels to be written in both French and English. Additionally, the guidance...
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    Adverse Events Push FDA to Recall Portable Oxygen Systems

    The US Food and Drug Administration (FDA) on Tuesday announced that it’s calling on consumers, businesses, schools and health providers to immediately stop using OxySure Therapeutics’ Portable Emergency Oxygen System, Model 615, after the company’s voluntary recall from last year was ineffective. FDA said it has received multiple complaints and reports of adverse events associated with the device’s malfunctions, including insufficient oxygen flow, re-breathing of exhale...
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    FDA: Foreign Device Inspections on the Rise

    Newly released data shows the US Food and Drug Administration (FDA) conducted fewer medical device quality systems inspections in 2015 compared to recent years, while the number of foreign inspections increased to their highest number in a single year. In total, FDA conducted 2,104 inspections in 2015, down from 2,213 in 2014, approximately five to seven percent fewer than it conducted between 2011 and 2014. Quality Systems Inspections, 2008-2015 (Source: FDA) Nearl...
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    New ISO 13485: Device Companies Have Three Years to Transition

    The International Organization for Standardization (ISO) late last month released its long-awaited revision to ISO 13485, the global standard for medical device quality management systems (QMS), which replaces the previous version from 2003. The new revision places a greater emphasis on QMS throughout the supply chain and product lifecycle, as well as device usability and postmarket surveillance requirements. Over the next three years, ISO 13485:2003 and ISO 13485:2016 ...
  • Feature ArticlesFeature Articles

    Evolution of Advertising and Promotion Review Systems

    This article addresses the evolution of review systems used for advertising and promotion materials. Promotional review and approval, at its root, is designed to ensure all marketing and sales materials for pharmaceuticals are compliant with established legal, regulatory and medical standards, as well as company policies and procedures. Pharmaceutical companies employ cross-functional teams applying standard principles of education and training and good judgment to eva...
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    Accessibility, Usability and Flexibility Critical for Regulatory Content Management

    The job of a regulatory professional has become increasingly global. According to RAPS' most recent Scope of Practice and Compensation Report , 72% of regulatory professionals in North America and Europe, have multiregional or worldwide scopes of work. There is a lot to keep track of in a large, global organization. Managing an organization's complex regulatory information and documentation across a global network of affiliates can be a significant challenge. ...
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    With Eye on Improving Quality, Indian Regulator gets First ISO Certification

    India’s regulatory authority has announced that one of its offices has become the first in the country to become certified by the International Organization for Standardization (ISO). In a press release, the Central Drugs Standard Control Organization (CDSCO) said that its Ahmedabad office received ISO 9001:2008 certification for its quality management system (QMS) on 16 February 2015. Background ISO 9001 is a set of standards for QMS in organizations where it is imp...