FDA released a final rule in January 2014 regarding required pediatric information that must be included in medical device PMA, HDE, and PDP submissions in order for the devices to be approved. To review the Final Rule entitled “Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on Pediatric Subpopulations That Suffer From a Disease or Condition That a Device Is Intended To Treat, Diagnose, or Cure“ on the Federal Register, click here. This rule became active on April 10, 2014. Alexander Gaffney from raps.org shared in his article that the draft of this rule was created in February. The reason for the rule is common sense shares Gaffney. “Products that are likely to be used by children should be able to be used safely by them. Safe use provisions require data. Therefore, companies should obtain data.” This is not unprecedented as the industry’s drug counterparts have been having to do this for a while The final rule says that companies will need to include any descriptions of pediatric populations that suffer from the disease that the device is intended to treat, prevent, diagnose, and cure. To read the full article click here.
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