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    Emergency use authorizations for IVDs: Building on lessons learned

    Emergency use authorization (EUA) is a tool used by the US Food and Drug Administration (FDA) for providing quick access to unapproved medical products in response to a public health emergency. In vitro diagnostics (IVDs) have been critical EUA products in past emergencies and have proven equally important during the COVID-19 pandemic. For regulatory professionals, the valuable lessons learned from EUA policy and ensuing changes over time have provided a crucial foundation...
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    The changing regulatory landscape for laboratory developed tests

    The COVID-19 pandemic has highlighted the importance of reliable and accurate diagnostic tests. Laboratory developed tests (LDTs) do not typically require premarket review. The US Food and Drug Administration (FDA) has repeatedly proposed more rigorous regulatory frameworks for LDTs but has been unsuccessful owing to concerns about the impact on test availability and innovation. In this article, the authors describe the existing regulations and consider both sides of the d...
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    Strategic lifecycle approach to medical device regulation

    The purpose of this article is to highlight new facets of EU Medical Device Regulation (MDR) in the medical device industry. The article contains references to both MDR legal articles and recommendations that will challenge organizations to take a more holistic viewpoint of their products, resources, and regulatory toolkit to be compliant in the EU.   Introduction The application date of 2017/745 MDR 1 is 26 May 2021, when it will officially supersede the 93/42/EC...
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    Federal officials design new mask guidelines to better protect more workers

    Federal officials announced new measures to help get fresh, new N95 masks to health care workers and expand their use in other industries after scientists argued that the highly protective masks are essential to keep workers safe from covid-19. The changes come as US mask-makers say the demand from hospitals is so sluggish that they’ve laid off 2,000 workers and fear some new protective gear companies could collapse. Yet in a letter to lawmakers, hospitals cite ongoing c...
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    Communication of regulatory intelligence: A survey of the medical device industry

    Regulatory intelligence activities are complicated by the push for stronger product sales in emerging markets, where medical device regulations can change rapidly or be confusing and even contradictory. Understanding how, when, and with whom to communicate the new or changing regulatory information within a medical device company affects global market strategy and product success. The research reported here examined how medical device companies structure their regulatory i...
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    MCIT: Not a better way to pay for breakthrough devices

    The Medicare Coverage of Innovative Technology (MCIT) pathway should be rescinded because it does not require thorough evidence of the safety and efficacy of the medical device for which it aims to provide coverage, Vinay K. Rathi, MD, of Harvard Medical School and colleagues wrote in a perspective published in the New England Journal of Medicine .   MCIT would provide up to four years of Medicare coverage for medical devices authorized under the US Food and Drug Admi...
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    Transforming regulatory strategy to meet the evolving compliance landscape

    Changes in industry regulations are now viewed as one of the top three disruptive business trends facing pharmaceutical and life sciences organizations today. These same pressures are extending to the medical device market. In this article, the authors explore how perception of regulatory compliance is evolving due to a variety of driving forces. They outline the role digital transformation can play in helping pharmaceutical companies meet new regulatory compliance demands...
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    FDA posts final guidance on device-specific performance criteria

    FDA has released three device-specific guidance documents detailing performance criteria in support of its Safety and Performance Based Pathway. The texts cover magnetic resonance (MR) receive-only coils, spinal plating systems and non-spinal metallic bone screws.   Last year, FDA published guidance on the optional Safety and Performance Based Pathway. The text set out the agency’s thinking on a pathway intended to enable companies to show a new product is as safe ...
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    Study calls for proactive surveillance of device AEs

    The US Food and Drug Administration (FDA) relies mainly on direct reports and regulator-initiated surveillance to flag safety concerns around medical devices, a system that may delay detection of adverse events (AEs), according to a new analysis published in JAMA Internal Medicine . “These data highlight the importance of proactive identification of postmarketing device-related safety issues to provide health care professionals with more complete data regarding potenti...
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    Breast implant label guidance finalized by FDA

    Updated 29 September to add comment from CDRH official The US Food and Drug Administration (FDA) issued final guidance on improving patient information regarding breast implants on 28 September. The final guidance largely echoes draft labeling guidance issued in October 2019, with some clarifications surrounding the relationship between implants and systemic disease, language to improve the readability of the patient device card, and information on specific registries...
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    FDA issues proposed rule clarifying stance on intended use

    After delaying implementation of parts of its final rule on intended uses multiple times, the US Food and Drug Administration (FDA) on Tuesday proposed a new rule clarifying its position on the types of evidence it will consider when determining a product’s intended use. The new rule would also repeal and replace the unimplemented portions of the earlier final rule.   The saga to update FDA’s intended use regulations began in 2015, when the agency first issued a propos...
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    FDA updates Pre-Cert pilot for SaMD

    Lessons learned from a digital health software pilot pre-certification program have readied the US Food and Drug Administration (FDA) to test an updated version of the continuous evaluation program for developers of software as a medical device (SaMD).   The precertification (Pre-Cert) pilot “will help inform the development of a future regulatory model that will provide more streamlined and efficient regulatory oversight of software-based medical devices,” said FDA in...