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  • Regulatory NewsRegulatory News

    CDRH Talks Up Timeliness of NEST

    Members of the committee governing the National Evaluation System for health Technology Coordinating Center (NESTcc), including US Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) Director Jeff Shuren, touted the timeliness of NEST in a commentary in Clinical Pharmacology & Therapeutics on Tuesday. Shuren and NESTcc executive director Rachel Fleurence explain how the time for NEST has now come as certain “characteristics of medical ...
  • Regulatory NewsRegulatory News

    NESTcc Unveils 2019 Operational Plan to Serve as ‘Front Door to Conduct RWE Studies’

    The center charged with coordinating the development of the National Evaluation System for health Technology (NEST) released a long-awaited “strategic and operational plan for 2019” on Friday. The committee governing the NEST Coordinating Center (NESTcc) approved a four-pronged 2019 action plan, which involves two “key areas” in which NESTcc “has refined its direction.” These relate to developing the NESTcc data network and planning for the center’s own sustainability. ...
  • Regulatory NewsRegulatory News

    NESTcc Selects 8 RWE Test Cases for Medical Devices

    The National Evaluation System for health Technology Coordinating Center (NESTcc), which is mutually funded by the US Food and Drug Administration (FDA) and industry, announced Monday it has selected a total of eight real-world evidence (RWE) test cases to evaluate medical device performance in clinical settings.   NESTcc based its selections on applications medical device manufacturers submitted in January under a public call for concepts initiated last year and s...
  • Regulatory NewsRegulatory News

    First Version of NEST to Launch in 2019

    The National Evaluation System for health Technology (NEST) will become increasingly crucial for tracking medical devices at FDA’s Center for Devices and Radiological Health (CDRH), though its creation continues to be fraught with limitations. The timeline for an initial version of the NEST Coordinating Center (NESTcc) is tight, Rachel Fleurence, NESTcc executive director, noted Wednesday at the MDEpiNet annual meeting at FDA’s White Oak campus. The idea for NEST origina...
  • Regulatory NewsRegulatory News

    NEST Seeks Medical Device Test Cases for Using Real World Evidence

    The National Evaluation System for health Technology Coordinating Center (NESTcc) this week put out three requests for proposals to help it build the case for using real world evidence for regulatory and coverage decisions for medical devices. Background In 2016, the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) awarded a $3 million grant to the Medical Device Innovation Consortium (MDIC) to establish NESTcc. The cente...