• 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...
  • Regulatory NewsRegulatory News

    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 A new draft guidance from the US Food and Drug Administration (FDA) provides a set of considerations to aid in determining into which category actions performed on devices should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   The new draft guidance “helps clarify whether activities performed on devices are likely remanufacturing,” wrote FDA’s Center for Devices and Radiological Health (CDRH) i...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 ) ...
  • Feature ArticlesFeature Articles

    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...
  • Regulatory NewsRegulatory News

    MDCG offers guidance on clinical investigations in Eudamed’s absence

    The European Commission’s Medical Device Coordination Group (MDCG) this week issued guidance providing a set of templates that will be used to fulfill the application/notification submission requirements for clinical investigations under the Medical Device Regulation (MDR) prior to the availability of the Eudamed clinical investigations and performance studies module.   Under MDR, sponsors of clinical investigations for medical devices are required to submit an appli...
  • Regulatory NewsRegulatory News

    FDA finalizes brain-computer interface guidance, issues draft for glycemic control devices

    The US Food and Drug Administration (FDA) has issued four medical device-related guidance documents. The new guidances address brain-computer interfaces, considerations in medical device design for the magnetic resonance imaging environment, clinical studies for devices to improve glycemic control and premarket notification submissions for peripheral atherectomy devices.   The four documents, one in draft and three in final form, were part of a larger swath of guidance...