FDA Issues New Device Manufacturer's Rule

WASHINGTON, March 31 (UPI) — The U.S. Food and Drug Administration says it is implementing a rule requiring medical device makers provide information pertaining to pediatric patients.

The FDA said such manufactures must supply information in certain pre-market applications on pediatric patients who suffer from a disease or condition that the device is intended to treat, diagnose or cure, even if the device is intended for adult use.


“Very few devices are developed or assessed specifically for use in pediatric patients — those 21 or younger at the time of treatment or diagnosis,” the FDA said in a statement. “This effort will provide a better understanding of which devices developed for use in adults should be assessed or modified for use in pediatric populations.”

Officials said the rule will also improve the agency’s ability to track the number of approved devices for which there is a pediatric subpopulation who could benefit and the number of approved devices labeled for use in pediatric patients.

If a manufacturer does not submit the required information, the FDA said it might not approve the application.

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