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August 22, 2017 5:00 pm

Nomination Deadline: Device Good Manufacturing Practice Advisory Committee and the Medical Devices Advisory Committee

  • Government
  • Agency
  • Genetics/Genomics
  • Neuroscience

The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on the Device Good Manufacturing Practice Advisory Committee and device panels of the Medical Devices Advisory Committee in the Center for Devices and Radiological Health. In accordance with the 21st Century Cures Act, this notice provides an annual opportunity for patients, representatives of patients, and sponsors of medical device submissions to provide recommendations for individuals with appropriate expertise to fill voting member positions on classification panels.

Among others, vacancies are available on the following committee panels:

  • Microbiology Devices Panel of the Medical Devices Advisory Committee—Infectious disease clinicians (e.g. pulmonary disease specialists, sexually transmitted disease specialists, pediatric ID specialists, tropical diseases specialists) and clinical microbiologists experienced in emerging infectious diseases; clinical microbiology laboratory directors; molecular biologists with experience in in vitro diagnostic device testing; virologists; hepatologists; or clinical oncologists experienced with tumor resistance and susceptibility.
  • Molecular and Clinical Genetics Devices Panel of the Medical Devices Advisory Committee—Experts in human genetics and in the clinical management of patients with genetic disorders, e.g., pediatricians, obstetricians, neonatologists. Individuals with training in inborn errors of metabolism, biochemical and/or molecular genetics, population genetics, epidemiology and related statistical training, and clinical molecular genetics testing (e.g., genotyping, array CGH, etc.). Individuals with experience in genetics counseling, medical ethics are also desired, and individuals with experience in ancillary fields of study will be considered.
  • Neurological Devices Panel of the Medical Devices Advisory Committee—Neurosurgeons (cerebrovascular and pediatric), neurologists (stroke, pediatric, pain management, and movement disorders), interventional neuroradiologists, psychiatrists, and biostatisticians.

More information is available via the Federal Register notice.