FMDIC.org

New and Noteworthy

  • FDA.gov gets a facelift [Video]
  • FDA proposes draft guidelines intended to improve the representation of women in medical device clinical studies [Press Release]
  • The Texas Department of State Health Services, Drug and Medical Device Division, writes about the use of Red Light Therapy Lamps in Tanning Devices
  • FDA issues two draft guidance documents to facilitate investigational medical device studies in humans [Press Release]
  • FDA seeks comment on streamlined review of lower risk, new technology, devices [Press Release]
  • FDA seeks comment on proposed guidelines for high-quality clinical studies [Press Release] [Draft Guidance]
  • FDA proposes guidelines that clarify benefit-risk determinations for medical devices [Press Release] [Draft Guidance]
  • FDA to seek public comment on IOM recommendations [Press Release]
  • FDA CDRH on the Investigational Device Exemption (IDE) for medical devices [Video]
  • FDA CDHR on Medical Device Innovation Initiative [Video]
  • Please welcome Mary Ellen Delaney (ASQ Biomedical), David Makanani (OKBIO), David Braeutigam (Association for the Advancement of Medical Instrumentation), John C. Criscione (Texas A&M University Department of Biomedical Engineering), and Steven Robertson (Medical Device Manufacturers Association) to FMDIC.
  • The Association of Food and Drug Officials (AFDO) has updated their Directory of State and Local Officials.
  • Networking, Social Media, and staying informed:

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