• 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

    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...
  • 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...
  • Regulatory NewsRegulatory News

    MCIT: Not a better way to pay for breakthrough devices

    The Medicare Coverage of Innovative Technology (MCIT) pathway should be rescinded because it does not require thorough evidence of the safety and efficacy of the medical device for which it aims to provide coverage, Vinay K. Rathi, MD, of Harvard Medical School and colleagues wrote in a perspective published in the New England Journal of Medicine .   MCIT would provide up to four years of Medicare coverage for medical devices authorized under the US Food and Drug Admi...
  • Feature ArticlesFeature Articles

    Transforming regulatory strategy to meet the evolving compliance landscape

    Changes in industry regulations are now viewed as one of the top three disruptive business trends facing pharmaceutical and life sciences organizations today. These same pressures are extending to the medical device market. In this article, the authors explore how perception of regulatory compliance is evolving due to a variety of driving forces. They outline the role digital transformation can play in helping pharmaceutical companies meet new regulatory compliance demands...
  • Regulatory NewsRegulatory News

    FDA posts final guidance on device-specific performance criteria

    FDA has released three device-specific guidance documents detailing performance criteria in support of its Safety and Performance Based Pathway. The texts cover magnetic resonance (MR) receive-only coils, spinal plating systems and non-spinal metallic bone screws.   Last year, FDA published guidance on the optional Safety and Performance Based Pathway. The text set out the agency’s thinking on a pathway intended to enable companies to show a new product is as safe ...
  • Regulatory NewsRegulatory News

    Study calls for proactive surveillance of device AEs

    The US Food and Drug Administration (FDA) relies mainly on direct reports and regulator-initiated surveillance to flag safety concerns around medical devices, a system that may delay detection of adverse events (AEs), according to a new analysis published in JAMA Internal Medicine . “These data highlight the importance of proactive identification of postmarketing device-related safety issues to provide health care professionals with more complete data regarding potenti...
  • Regulatory NewsRegulatory News

    Breast implant label guidance finalized by FDA

    Updated 29 September to add comment from CDRH official The US Food and Drug Administration (FDA) issued final guidance on improving patient information regarding breast implants on 28 September. The final guidance largely echoes draft labeling guidance issued in October 2019, with some clarifications surrounding the relationship between implants and systemic disease, language to improve the readability of the patient device card, and information on specific registries...
  • Regulatory NewsRegulatory News

    FDA updates Pre-Cert pilot for SaMD

    Lessons learned from a digital health software pilot pre-certification program have readied the US Food and Drug Administration (FDA) to test an updated version of the continuous evaluation program for developers of software as a medical device (SaMD).   The precertification (Pre-Cert) pilot “will help inform the development of a future regulatory model that will provide more streamlined and efficient regulatory oversight of software-based medical devices,” said FDA in...
  • Feature ArticlesFeature Articles

    Current Chinese NMPA clinical pathways for medical device registration

    This article presents the key highlights of the current clinical pathways for registering medical devices in China and discusses when the various clinical pathways should be used, based on the country's National Medical Products Administration (NMPA) regulations and guidances. Introduction The NMPA, 1 formerly known as the China Food and Drug Administration, is the Chinese agency responsible for regulating drugs and medical devices. In addition to the national NMPA, ...
  • Regulatory NewsRegulatory News

    European Commission sets common specifications for reprocessing single-use devices

    The European Commission this week issued regulations establishing common specifications for the reprocessing of single-use medical devices under the Medical Device Regulation (MDR).   Under MDR, single-use devices may be reprocessed where permitted by national law. Member states may also determine what rules they will apply to single-use devices reprocessed and used within a health institution, so long as the reprocessing is performed in accordance with the common sp...
  • Regulatory NewsRegulatory News

    FDA qualifies decision tool for breast reconstruction studies

    The BREAST-Q Reconstruction Module now is qualified as a medical device development tool (MDDT) to aid sponsors and investigators in developing feasibility, pivotal and post-approval studies of medical devices used in breast reconstruction, the US Food and Drug Administration (FDA) announced. “An MDDT is scientifically validated and can be qualified for use in device evaluation and to support regulatory decision-making,” according to the announcement , which noted its ...