• Feature ArticlesFeature Articles

    Update on FDA regulation of ophthalmic combination products

    Ophthalmic products are regulated under quality standards published in the Code of Federal Regulations (CFR), United States Pharmacopeia (USP), and various US Food and Drug Administration (FDA) guidance. Application of these standards has recently been affected by the legal requirement for the FDA to standardize the regulatory approach to ophthalmic products whose components are considered devices. The agency communicated the update through a guidance outlining the phase-i...
  • Feature ArticlesFeature Articles

    Regulatory ad promo in a co-promotion setting

    Co-promotion agreements between two pharmaceutical companies amplify marketing efforts for a product and boost market penetration. It entails collaboration between the companies during the review and approval of the promotional and nonpromotional product information materials. This article will focus on co-promotion in the regulatory advertising and promotion (ad promo) setting. It includes basic principles and best practices in implementing the promotional review process ...
  • Feature ArticlesFeature Articles

    Foods for special medical purposes/medical foods: A global regulatory synopsis

    This two-part article covers the specific requirements for placing foods for special medical purposes (FSMPs) on the market in major jurisdictions – EU, UK, US, China, and other regions of the world – to improve the role of nutrition in support of optimal care for patients. Part 1 covers general principles governing FSMPs, use of FSMPs in community and hospital settings, common regulatory challenges, opportunities for category growth, and considers a multistakeholder initi...
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    Here’s what’s new in Fundamentals of Medical Device Regulations, Fifth Edition

    Changing regulations are nothing new for regulatory professionals operating in the medical device sector, but 2022 cemented milestones no one in the profession can ignore. The fifth edition of Fundamentals of Medical Device Regulations provides a current view of regulations governing medical devices and IVD and addresses the impact of the application of EU Medical Device Regulation (EU MDR) and In Vitro Diagnostic Regulation (EU IVDR) as well as other important changes to...
  • Regulatory NewsRegulatory News

    Medtech Industry: FDA emergency product shortage reporting guidance is too broad, burdensome

    Draft guidance from the US Food and Drug Administration on reporting medical device and diagnostic shortages for public health emergencies is too broad and potentially could be too resource intensive for manufacturers as well as regulators, representatives from medtech industry groups believe.   In January, the FDA published a draft guidance that outlines when and how the agency wants medtech manufacturers to alert the agency of potential product shortages that happen ...
  • RF Quarterly

    Software development

    This article applies to software development and validation and discusses the security and usability engineering aspects of software. It uses the term “software” for software as a medical device (SaMD) and medical device software (MDSW), including MDSW that is embedded on, drives, or influences the use of a hardware medical device, software accessories, and software components.  Keywords ‒ agile, development, incremental, software, static, waterfall   Standards an...
  • RF Quarterly

    Clinical evaluation of software

    Software has become an increasingly critical area of healthcare product development. Rapid technological advancement has resulted in substantial changes to software function and acceptance, leading to a growing number of novel medical devices capable of informing, driving, or replacing clinical choices, or directly providing therapy. Regulatory authorities expect that clinical evidence for a software as medical device (SaMD) is generated with a scientific level of rigor th...
  • RF Quarterly

    Security risk management

    Risk management is focusing increasingly on cybersecurity related ri sks, which can have an impact on human health, environment, and property. With the increasing threats of cyberattacks on the critical infrastructures, including healthcare, the need for secure products and services is becoming more prominent. Recent global development in which cyberwarfare has become a major issue further emphasize the need for good security management, as the chain is only as strong as...
  • Regulatory NewsRegulatory News

    MDUFA V: Commitment letter includes TPLC pilot, claw back provisions and more

    The new medical device user fee deal includes the US Food and Drug Administration’s (FDA) total product lifecycle (TPLC) advisory program, or TAP, as well as new guidance development requirements and claw back provisions that let industry renegotiate fees. If signed into law as is, it would bring in $1.78-$1.9 billion over the next five years.   FDA finally published a commitment letter on 22 March summarizing the Medical Device User Fee Amendments (MDUFA V) deal i...
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    Shuren: Let’s take regulatory flexibility beyond COVID-19

    Congressionally authorized regulatory flexibility could provide medical device manufacturers with more options and help the US Food and Drug Administration (FDA) better monitor product safety and efficacy, according to Jeff Shuren, director of the FDA Center for Devices and Radiological Health (CDRH).   “There really is a need for more flexibility to have agile regulation,” said Shuren during a fireside chat on 22 March at the Duke-Margolis Center for Health Policy’s d...
  • Regulatory NewsRegulatory News

    Report: Using RWD to evaluate AI-enabled clinical decision support tools

    A new analysis from the Duke-Margolis Center for Health Policy outlines the data elements that real-world data (RWD) sources would need to capture in order to evaluate the performance of artificial intelligence (AI)-enabled clinical decision support tools, as well as the ongoing challenges related to data quality, privacy and security.   AI-enabled clinical decision support tools can be difficult to evaluate after deployment because of the non-standardized nature of el...
  • Regulatory NewsRegulatory News

    Digital health tech in clinical investigations: FDA issues draft guidance

    The US Food and Drug Administration, as part of an end-of-year spate of guidance documents, has issued a draft guidance for sponsors who wish to use digital tech to aid in remote clinical data acquisition.   Digital health technologies (DHTs) stand to benefit clinical investigations in a multitude of ways, but regulatory considerations have to be weighed as the technologies are employed, noted the agency in setting out the background for the draft guidance, issued in l...