USA – FDA seeks public comments on pediatric medtech applications

  • FDA is seeking comments from the public on information required for submitting medical device applications for pediatric populations.
  • The agency is asking for input on whether the proposed collection of information is necessary for it to perform its functions, on the accuracy of the estimated burden of gathering the information, ways to enhance the usefulness of the information collected, and ways to minimize the burden on respondents.
  • The information it collects will help in tracking how many devices are approved to treat, diagnose or cure a condition affecting a pediatric subpopulation and the review time for those applications, FDA said in a notice published Friday…