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FDA Assembling Advisors To Discuss Pediatric HDE Products

As part of a periodic review, FDA is bringing together experts to review several products that are conditionally available for pediatric use under the agency's Humanitarian Device Exemption program.

FDA's Pediatric Advisory Committee (PAC) is scheduled to meet for two days in mid-September to discuss a range of products, including four devices with humanitarian device exemptions (HDE) for use in kids.

In an Aug. 22 Federal Register notice, FDA says it is convening its panel of pediatric experts in Gaithersburg, Md., on Sept. 11 and 12. The first day...

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