Press Release

Review of FDA Premarket Assessment of Pediatric Medical Devices

March 29, 2014

VICTORIA, British Columbia, March 28, 2014 – StarFish Medical announces availability of its review of the new FDA Guidance document titled “Premarket Assessment of Pediatric Medical Devices”, summarizing the FDA’s expectations for regulatory submission in the areas of:

  • Pediatric Population and use
  • Unique Characteristics of Pediatric Patients
  • Clinical Data
  • Labelling
  • Protection for Pediatric population in clinical studies

Download the review here.

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