• Regulatory NewsRegulatory News

    MDCG offers guidance on clinical investigations under MDR

    In new questions and answers guidance released last week, the European Commission’s Medical Device Coordination Group (MDCG) offers advice to device makers on the appropriate regulatory pathways and other considerations for conducting clinical investigations under the Medical Device Regulation (MDR).   The 19-page document features 28 questions and answers as well as two annexes charting the regulatory pathways for clinical investigations and a non-exhaustive list of...
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    MDUFA V: Deficiency letters, staffing and funding emerge as issues in early negotiations

    After a delayed start, the US Food and Drug Administration (FDA) released minutes from the first two meetings held with the medical device industry to negotiation the terms of the next Medical Device User Fee Amendments (MDUFA V) program.   FDA and industry had originally planned to kick off the MDUFA V negotiations with a public meeting last April, but the meeting was delayed by six months due to COVID-19. (RELATED: MDUFA V: Industry wants fine tuning while FDA se...
  • ReconRecon

    Recon: Abbott profits triple with OTC test launch; Good news for bluebird

      Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Large clinical trial to study repurposed drugs to treat COVID-19 symptoms ( NIH ) Q&A with Acting FDA Commissioner Janet Woodcock on the Future of the FDA ( BioSpace ) Covid cases, vaccinations remain elevated as U.S. nears Biden’s 200 million goal ( CNBC ) U.S. CDC expands COVID-19 vaccine eligibility to 16 and older ( Reuters ) Johnson & Johnson reports...
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    FDA issues final rule removing certain software from medical device regulations

    The US Food and Drug Administration (FDA) has issued a final rulemaking that eliminates certain software intended to transfer, store or display clinical laboratory tests from being regulated as medical devices.   This action was taken to conform to the medical software provisions of the 21 st Century Cures Act , enacted on 13 December 2016. The law amended the definition of a device in the Federal Food, Drug, and Cosmetic Act (FD&C Act) to exclude such software; th...
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    FDA walks back Trump-era premarket notification exemptions

    The US Food and Drug Administration (FDA) on Thursday took steps to undo a sweeping deregulatory move that was pushed through by the Department of Health and Human Services (HHS) in the final days of the Trump administration.   With less than a week left in the previous administration, HHS published a notice in the Federal Register exempting seven types of surgical and patient examination gloves and proposing to permanently exempt more than 80 Class II devices and on...
  • ReconRecon

    Recon: ThermoFisher acquires PPD for $17.4B; First chimeric human-monkey embryos

      Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Daily U.S. Covid cases remain above 70,000 amid Johnson & Johnson vaccine pause ( CNBC ) Fauci, Jim Jordan spar over pandemic restrictions ( The Hill ) What’s behind the wait on a J&J vaccine verdict ( Politico ) ( NYT ) ( WSJ ) The J&J Vaccine Pause Is Science Working Like It’s Supposed To ( Slate ) Why the Johnson & Johnson pause may not matter for Amer...
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    FDA updates on ASCA pilot, lists accredited test labs

    In an important step in the rollout of its accreditation scheme for conformity assessment (ASCA) pilot, the US Food and Drug Administration (FDA) this week published its initial list of accredited testing laboratories participating in the program.   The pilot, which arose out of the negotiations for the current Medical Device User Fee Amendments (MDUFA IV) program, is meant to increase “consistency, predictability and efficiency” during the premarket review of medica...
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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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    MDR/IVDR: Commission updates on implementation, notified body designation

    The European Commission last week updated its rolling plan detailing the actions and initiatives necessary to ensure the smooth rollout of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).   With MDR’s date of application just weeks away, Finland’s Eurofins Expert Services Oy on Wednesday became the 20 th notified body designated under the regulation. Just four notified bodies have been designated under IVDR.   Based on the pipeli...
  • Feature ArticlesFeature Articles

    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...
  • ReconRecon

    Recon: EMA says 'possible' AZ-blood clot link; Invitae's $1.2B gene testing investment

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US U.S. begins study on allergic reaction risk in Moderna, Pfizer vaccines ( NIH ) ( Reuters ) CDC says variant from the UK is now the most common strain circulating in the U.S. ( CNBC ) U.S. delivering about 3 million COVID-19 vaccines per day, up 8%: CDC director ( Reuters ) U.S. surpasses 150 million vaccine shots under Biden, on track to hit President’s new 2...
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    How to reduce bias, improve fairness in medical devices

    Lessons learned in the artificial intelligence community about addressing bias could also be applied to medical devices, according to a recent perspective in the journal Science .   “Initiatives to promote fairness are rapidly growing in a range of technical disciplines, but this growth is not rapid enough for medical engineering. Although computer science companies terminate lucrative but biased facial recognition systems, biased medical devices continue to be sold a...