• Regulatory NewsRegulatory News

    EMA goes all in on big data

    The European Medicines Agency (EMA) and the EU’s Heads of Medicines Agencies (HMA) have issued an ambitious workplan for a joint steering group to tackle issues related to big data in healthcare and medicines development.   The steering group’s 2021-2023 work plan, adopted in June and published Friday, “aims to increase the utility of big data in regulation, from data quality through study methods to assessment and decision-making,” according to EMA’s big data webpage...
  • Regulatory NewsRegulatory News

    Vagal nerve stimulator for stroke rehab nabs FDA nod

    The first-ever vagal nerve stimulation system for chronic ischemic stroke rehabilitation has received approval through the US Food and Drug Administration’s (FDA’s) most stringent pathway.   The vagal nerve stimulation (VNS) system will be marketed by MicroTransponder as the Vivistim Paired VNS System. The device enters the market through FDA’s premarket approval pathway after receiving breakthrough device designation.   "People who have lost mobility in their hand...
  • ReconRecon

    Recon: FDA investigates iPhone-pacemaker interference; Humacyte's $245M SPAC deal

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA warns of pacemaker-iPhone interference ( Healthcare IT News ) Opinion: Expanding the domestic public health supply chain is a matter of national security ( STAT ) BD gets emergency FDA nod for smartphone-enabled COVID-19 antigen test ( MedTech Dive ) Ivermectin Scripts, Poison Center Calls Boom During Delta Surge ( MPT ) U.S. COVID-19 tests again in short...
  • Regulatory NewsRegulatory News

    FDA warns Japanese firm for particle contamination, takes mask-maker to task — again

    The US Food and Drug Administration (FDA) admonished Japanese pharmaceutical manufacturer Toyoba Co. in a recent warning letter for taking a lax approach to fixing microbiological contamination issues and resolving data integrity problems that included falsification of data.   The firm’s failure to report accurate data “compromised the sterility assurance of drug products released from the facility and may have increased risks to patients,” wrote FDA in the 19 August...
  • ReconRecon

    Recon: Pharma's rep down again; Roche ponies up $3B for Shape's RNA editing tech

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Six U.S. states do not join $26B opioid settlements with distributors, J&J ( Reuters ) ‘We Sent a Terrible Message’: Scientists Say Biden Jumped the Gun With Vaccine Booster Plan ( KHN ) Fauci says he hopes U.S. will have ‘some good control’ over Covid by spring 2022 ( CNBC ) American Medical Association calls for public, private sectors to mandate vaccines ( ...
  • Regulatory NewsRegulatory News

    FDA affirms increased risk with pelvic mesh products

    The US Food and Drug Administration (FDA) announced on Monday that its review of final results from postmarket surveillance of transvaginal mesh devices meant to treat pelvic organ prolapse (POP) found that patients who received mesh repair had increased risk of mesh exposure and tissue erosion compared to patients whose prolapse was repaired with native tissue.   “Therefore, the FDA continues to believe that these devices do not have a favorable benefit-risk profile,”...
  • Feature ArticlesFeature Articles

    An overview of recent FDA activity on materials in medical devices

    In this article, the authors provide an overview of recent US Food and Drug Administration (FDA) interest and activity relating to the materials in implants regulated as medical devices. Since 2019, the increase in public and regulatory scrutiny of medical implants has resulted in an FDA advisory committee meeting, revised corrosion testing guidance, and proposed new labeling disclosures.   Introduction Medical devices offer innovative ways of treating various cond...
  • Regulatory NewsRegulatory News

    FDA's FY2022 Senate funding bill clears Appropriations committee

    The Senate Appropriations committee has completed its markup of the FY2022 budget for the US Food and Drug Administration (FDA), advancing by a 25-5 vote a bill that would hold the agency to a $200 million increase in its budget authority.   The bill exited the Appropriations subcommittee responsible for FDA funding on Monday with no objections to the Senate’s proposed 6% increase for the agency over FY2021 figures. (RELATED: Senate subcommittee advances FY2022 FDA f...
  • Regulatory NewsRegulatory News

    Notified bodies report success — and some drawbacks — using remote audits

    Remote audits conducted by notified bodies have been successful in ensuring that medical device manufacturers are complying with the EU’s Medical Device Regulation and In Vitro Diagnostics Regulation, according to a recently conducted survey  of 46 notified bodies, with remote audits uncovering roughly the same number of deficiencies as onsite audits.   The survey was conducted by the European Association of Medical Device Notified Bodies (TEAM NB), located in Liège...
  • Regulatory NewsRegulatory News

    Review: FDA device approval pathways more complex than ever

    The regulation of medical devices in the US has grown increasingly complex, with multiple pathways to gain marketplace entry and a shift toward collecting evidence in the postmarket setting.   The findings come from a sweeping study of more than 40 years of medical device regulation by the US Food and Drug Administration (FDA), beginning with the Medical Device Amendments of 1976, which first provided the agency with premarket review authority for devices. The analysis...
  • Regulatory NewsRegulatory News

    FTC to focus enforcement action on illegal repair restrictions

    In a unanimous vote, the Federal Trade Commission (FTC) has decided to focus law enforcement efforts on repair restrictions that impede or prevent consumers and businesses from repairing products they own.   “While unlawful repair restrictions have generally not been an enforcement priority for the Commission for a number of years, the Commission has determined that it will devote more enforcement resources to combat these practices,” FTC said in a new policy statemen...
  • Regulatory NewsRegulatory News

    Digital health collaborative aims to build in equity and inclusion

    A newly minted collaborative of industry, government, and patient groups is seeking to develop a set of best practices that will help make digital health measurement technologies work for all users, regardless of gender, race, ethnicity, and other factors.   The Digital Health Measurement Collaborative Community ( DATAcc ), launched in May 2021, is hosted by the nonprofit Digital Medicine Society (DiMe) and brings together more than 30 organizations, including the US F...