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Posted by Stephani Hulec on Fri, Jul 20, 2018

A Step Forward for Pediatric Devices?

The FDA defines pediatric medical devices as those that “treat or diagnose diseases and conditions from birth through age 21”.  As many are aware, the medical device industry has a continuing lack of approved devices for pediatric use.  This is due to a variety of barriers, as noted in this 2004 Report to Congress, such as the small market for these devices, difficulty in obtaining clinical data for FDA approval, and increased liability for working such this vulnerable population.  The FDA has formed a Pediatric Device Consortia (PDC) Grant Program specifically to support the development of pediatric device innovation.  IMARC recently published a blog  on this topic, discussing how the PDC FDA group has provided funding to several chosen non-profit organizations and research consortia in an attempt to jumpstart the advancement of new pediatric devices.

Topics: Pediatric Medical Devices, FDA, PMA

Posted by Brandy Chittester on Wed, Mar 04, 2015

PMA & 510(k): Disagreements Regarding Device Reviews

The Department of Health and Human Services (HHS) is the United States government’s principal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves, according to the government website.

Topics: The Department of Health and Human Services, 510(k), PMA

Posted by John Lehmann on Fri, Jun 03, 2016

How Would You Make Humanitarian Device Applications Better?

FDA is currently seeking comments on the collection of information regarding the Humanitarian Device Exemption (HDE) applications and related requirements. As summarized by an article in MassDevice, the FDA is interested in learning:

Topics: Medical Devices, FDA, PMA, Humanitarian Device Exemption

Posted by John Lehmann on Wed, Mar 04, 2015

PMA & 510(k): Disagreements Regarding Device Reviews

The Department of Health and Human Services (HHS) is the United States government’s principal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves, according to the government website.

Topics: FDA, 510(k), PMA, Device Reviews

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