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  • 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    Draft guidance from the US Food and Drug Administration on reporting medical device and diagnostic shortages for public health emergencies is too broad and potentially could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   In January, the FDA published a draft guidance that outlines when and how the agency wants medtech manufacturers to alert the agency of potential product shortages that happen ...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...
  • Regulatory NewsRegulatory News

    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...
  • ReconRecon

    Recon: Elizabeth Holmes found guilty of four counts of fraud; Another big Paxlovid deal

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US More than 1 million Americans were diagnosed with COVID over the long holiday weekend ( NPR ) ( Reuters ) Elizabeth Holmes is found guilty of four counts of fraud ( NYT ) ( POLITICO ) The Epic Rise and Fall of Elizabeth Holmes ( NYT ) Pfizer carries pandemic momentum into 2022, scoring another huge Paxlovid deal with the US ( Fierce ) CDER, CBER Approve Total...
  • Regulatory NewsRegulatory News

    This week at FDA: Medtronic MiniMed problems; Device classification flurry

    Welcome to 2021’s last issue of This Week at FDA. This week saw a year-end flurry of device classifications; we are also sharing news of three noteworthy device warning letters and a citizen petition response that closes with FDA’s referring a firm to the Federal Trade Commission (FTC) for anticompetitive practices.    RAPS offices are closed 23 December – 2 January. Regulatory Focus will resume publication on 3 January. From our team to you, our valued readers, best...
  • Regulatory NewsRegulatory News

    EC outlines rules for electronic IFU for med devices

    The European Commission has issued rules outlining the circumstances in which medical device instructions for use (IFU) can be provided in electronic form, rather than in paper form.   The implementing regulation , issued on 14 December, brings the European Union into alignment with device regulators in the US, Australia, and other nations, which already allow electronic labeling/IFU for certain medical devices. (RELATED: TGA Offers Guidance on Electronic Instructio...
  • Regulatory NewsRegulatory News

    Recon: Califf's Senate hearing; Moderna, Amgen pull out of JPM

      Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Former FDA commissioners endorse Califf as head of agency, citing urgency of addressing omicron ( WaPo ) Califf goes to Congress ( POLITICO ) Moderna, Amgen among biotech heavyweights pulling out of JPM conference over Covid concerns ( STAT ) US FDA’s Woodcock Sees Clinical Trial Reform Coming, But ‘Not Wholly Optimistic’ ( Pink Sheet ) Pfizer says its Co...