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  • Regulatory NewsRegulatory News

    FDA announces stronger warnings on breast implant labels

    The US Food and Drug Administration on 27 October announced new labeling, including boxed warnings, to facilitate informed consumer decision-making regarding the risks of breast implants.   FDA is also restricting the sale and distribution of breast implants to providers who agree to provide patients with adequate information on their risks by reviewing a decision checklist with patients. The physician performing the breast implant must sign the checklist, and patien...
  • Regulatory NewsRegulatory News

    Europe’s MDCG offers guidance on legacy medical devices, repackaging

    A new guidance document from the European Commission’s Medical Device Coordination Group (MDCG) spells out how the newly implemented Medical Device Regulation (MDR) will be applied to legacy devices and devices placed on the market prior to the 26 May 2021 MDR rollout.   In the guidance , MDCG takes the position that the MDR’s post-market surveillance, market surveillance, and vigilance requirements apply to legacy devices. The surveillance of legacy devices by notifi...
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    FDA nixes GUDID submission requirements for class I consumer healthcare devices

    Manufacturers of class I medical devices considered to be consumer healthcare products will get a reprieve from complying with the US Food and Drug Administration’s (FDA) Global Unique Device Identification Database (GUDID) submission requirements under a draft guidance issued on Wednesday.   Under the agency's unique device identification (UDI) compliance policy guidance issued in June 2020, class I devices, other than implantable, life-supporting, and life-sustaini...
  • Feature ArticlesFeature Articles

    Best practices and education for probiotics amid regulatory uncertainty

    Nearly 3 years have passed since the US Food and Drug Administration (FDA) issued its draft guidance for industry on the labeling of probiotic quantity. During that time, consumer interest in probiotics has increased, product innovation has expanded, and the body of scientific research has grown – all with no final guidance or updates from the agency. With the growth of this category and continued regulatory uncertainty, responsible industry has stepped up with best practi...
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    EMA preps for EU common standard on electronic product information

    The European Medicines Agency (EMA) this week launched a stakeholder consultation on a draft EU common standard for electronic product information (ePI) for human medicines.   The common standard would provide a semi-structured template for ePI incorporating the authorized, statutory product information for medicines, including the summary of product characteristics (SmPC), labeling and package leaflet. EMA says that ePI will be better suited “for electronic handling a...
  • 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...
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    FDA pushes back deadline for removal of legacy identifiers to 2023

    After receiving pushback from industry, the US Food and Drug Administration (FDA) on Thursday said it will give medical device makers two more years to remove legacy identification numbers from their product labels and packages.   Under FDA’s 2013 unique device identification (UDI) final rule, medical device labels and packages are required to bear a UDI according to the schedule set in the final rule, with some exceptions and alternatives for certain devices. The UDI ...
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    Drug labeling authority, UDI program reviewed by Harvard-based researchers

    Two papers in JAMA Internal Medicine highlighted separate, but important issues concerning the US Food and Drug Administration’s authority to modify package inserts and the effect of a recently shuttered agency initiative.   In a Viewpoint, Bishal Gyawali, MD, PhD, and colleagues at the Program on Regulation, Therapeutics and Law (PORTAL) research group at Harvard Medical School and Brigham & Women’s Hospital suggested improving FDA’s authority to modify drug package...
  • Feature ArticlesFeature Articles

    March's Regulatory Focus: Regulatory intelligence

    Feature articles during March focused on regulatory intelligence (RI), including first-hand accounts of setting up a dedicated process for RI monitoring and developing an in-house RI database, as well as an examination of the implications of the US Food and Drug Administration’s (FDA’s) new integrated review template for RI. Also included were articles on the importance a global unique device identification (UDI) system, the FDA’s Bad Ad program, and the importance of writ...
  • Feature ArticlesFeature Articles

    The importance of the device label to a global UDI system

    Variance between medical device regulations in different jurisdictions complicates creation of a global unique device identification (UDI) system, causing compliance barriers for manufacturers and adoption barriers for device users. As regulatory agencies advance their UDI initiatives, we reflect on the principles guiding this system not only for regulatory purposes, but as essential to improving the value of healthcare supply chain, clinical, and research data. This artic...
  • Regulatory NewsRegulatory News

    Health Canada drafts guidance on electronic media in labeling

    Health Canada last week launched a public consultation on its draft guidance for drugmakers on incorporating electronic media, such as websites or mobile applications, in prescription drug labeling.   The public consultation runs until 7 May 2021 and seeks feedback from industry, health professionals and the public on the agency’s proposed guidance. The draft guidance is built around Health Canada’s existing legal framework for labeling and explains the agency’s expect...
  • Regulatory NewsRegulatory News

    EMA offers labeling flexibilities for COVID therapeutics

    After providing flexibility on labeling requirements for COVID-19 vaccines last year, the European Medicines Agency (EMA) on Monday offered guidance on when those flexibilities could be applied to COVID-19 therapeutics.   The temporary labeling and packaging flexibilities for COVID-19 vaccines are outlined in a memorandum of understanding between the European Commission and EU member states and a questions and answers guidance from EMA . The flexibilities include al...