• Regulatory NewsRegulatory News

    Shuren: Time to rethink FDA's device regulatory framework

    Rethinking the medical device regulatory framework has been on the mind of Jeffrey Shuren, MD, JD, director of the Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration (FDA), especially in light of lessons the agency learned during the COVID-19 pandemic.   When he became director at CDRH in 2009, Shuren said, the medical device industry was in a different place. “Innovators were bringing their technologies overseas, first due to incr...
  • Regulatory NewsRegulatory News

    MDUFA V: FDA proposes TPLC advisory panel, industry says ‘back to basics’

    Minutes from the latest round of negotiations between the US Food and Drug Administration (FDA) and industry around the next iteration of the Medical Device User Fee Amendments (MDUFA V) have been released to the public and highlight how stakeholders are approaching the talks with different goals in mind.   Negotiations for MDUFA V began this year after months of delays due to the COVID-19 pandemic. Last year, a public kick-off meeting was pushed from April 2020 to Oct...
  • EC proposes crisis-related devices role for EMA

    The European Council (EC) has proposed that the European Medicines Agency (EMA) take a stronger role in crisis management and preparedness, increasing its administrative oversight of medicinal products and also medical devices during emergencies such as the recent COVID-19 pandemic.   The proposal, first drafted in November 2020, is part of a triad of documents “aiming to strengthen the EU's health security framework and to reinforce the crisis preparedness and respons...
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    FDA explains when device 'servicing' becomes 'remanufacturing'

    At what point does manipulation or repair of a medical device cross the line from “servicing” to “remanufacturing?” A new draft guidance from the US Food and Drug Administration (FDA) provides a set of considerations to aid in determining into which category actions performed on devices should fall.   The new draft guidance “helps clarify whether activities performed on devices are likely remanufacturing,” wrote FDA’s Center for Devices and Radiological Health (CDRH) i...
  • ReconRecon

    Recon: Novavax COVID-19 vax 90%-plus effective; GSK pays big for Iteos' TIGIT-targeted immunotherapy

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Novavax Offers U.S. a Fourth Strong Covid-19 Vaccine ( NYT ) ( NPR ) ( Reuters ) Another Sad Coronavirus Pandemic Milestone Is Approaching ( NPR ) U.S. Not On Pace To Meet Biden's Vaccination Goal ( NPR ) Eight states see rise in new COVID-19 infections ( The Hill ) U.S. has administered over 309 million doses of Covid-19 vaccines, CDC says ( CNBC ) How did ...
  • Regulatory NewsRegulatory News

    Italian firm falsified sterilization data, FDA warns device firms

    An Italian firm that processes medical devices has been falsifying data, including information related to sterilization certificates, since 2016, according to the US Food and Drug Administration (FDA).   As many as 97 different medical device manufacturers may be affected, wrote FDA’s director of the Office of Product Evaluation and Quality for the Center for Devices and Radiological Health (CDRH), William Maisel, in a letter to medical device manufacturers. He wrote...
  • RF Quarterly

    Modernizing medical devices regulation for AI and ML: GHWP efforts

    The recent progress of artificial intelligence (AI) technologies has had a pivotal impact on the healthcare system. Medical device manufacturers use these technologies to develop new and innovative products for better health outcomes. However, these technologies have introduced new challenges to the medical field. There is a need to have a novel medical device regulatory framework that addresses these challenges. This article addresses the impact of AI on the medical devic...
  • Ophthalmic manufacturers get UDI guidance from MDCG

    In a new position paper, the EU’s Medical Device Coordination Group (MDCG) has provided detailed information about device identifiers for eyeglass and lens manufacturers.   The position paper is meant to clarify how manufacturers of spectacle lenses and “ready readers,” or non-prescription reading glasses, should address unique device identification (UDI) requirements under the newly applied Medical Devices Regulation (MDR).   Articles 10(7) and 27(3) of the MDR ob...
  • Regulatory NewsRegulatory News

    MDR's Day One: Experts weigh in

    Editor’s note: Today, MDR comes into effect. We took the opportunity to check in with medical device regulatory experts now that the day is at hand. This “ News in Focus ” article is the first in an occasional series where we will provide expert perspective or opinion on regulatory news. Look to Regulatory Focus for more insights on other topics in the coming weeks.   In the EU, the day has come. On Wednesday, the European Commission applied the updated suite of re...
  • ReconRecon

    Recon: CMS head confirmed; EU seeks breach-of-contract fine from AZ

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biden's CMS head confirmed, but FDA pick remains elusive ( Axios/Yahoo ) BARDA Funding Freeze Risks Companies Abandoning COVID Therapeutic Work ( Pink Sheet ) CDC: Half of US adults now vaccinated against COVID-19 ( The Hill ) Pandemic creates 500-site backlog for FDA, despite decade of dwindling US inspections ( Pharma Tech ) The Vaccine Rollout Is Changing ...
  • ReconRecon

    Recon: ASCO 21 updates; Moderna goes for teen EUA

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Moderna says that its vaccine is effective for 12- to 17-year-olds and that it will seek F.D.A. authorization ( NYT ) ( NPR ) President Biden still hasn’t appointed a permanent FDA commissioner. That has big implications for upcoming drug approvals ( Fortune ) Bipartisan Legislation Introduced to Advance Biomedical Research Stalled by Pandemic ( Global Genes ) ...
  • Regulatory NewsRegulatory News

    CDRH seeks feedback on proposed materials labeling framework

    The US Food and Drug Administration (FDA) is asking stakeholders for comment on how it should communicate information about materials contained in medical devices to healthcare providers and the public.   FDA’s Center for Devices and Radiological Health (CDRH) recently published a discussion paper, titled, “Conveying Materials Information about Medical Devices to Patients and Healthcare Providers: Considerations for a Framework,” that is intended to facilitate discussi...