Pediatric devices still have few premarket studies in children

April 15, 2014
Pediatric devices still have few premarket studies in children

(HealthDay)—Most high-risk pediatric devices are approved based on trials that don't involve children under 18 years of age, according to a study published online April 14 in Pediatrics.

Thomas J. Hwang, from Harvard University in Boston, and colleagues identified all high-risk (class III) devices approved through the U.S. Food and Drug Administration's (PMA) or humanitarian device exemption pathways for use in children (between 2008 and 2011). Clinical trial design (randomization, blinding, controls, and types of end points), age distribution of trial participants, and FDA-mandated postmarketing trials were identified.

The researchers found that, over the study period, 22 devices were approved for use in via the PMA pathway and three via the humanitarian device exemption pathway. The majority of devices (88 percent) qualified as pediatric despite minimum approval ages of ≥18 years (the FDA considers aged 18 to 21 years old as pediatric). Nonrandomized (59 percent), open-label (68 percent) studies with surrogate effectiveness end points (77 percent) contributed to most device approvals. Most devices (84 percent) were not studied in any patients younger than 18 years of age. Roughly three-quarters of devices were mandated to have postmarketing studies, although only three required enrollment of .

"Most high-risk pediatric devices are approved on the basis of trials in patients ≥18 years old, with few pediatric patients exposed to the devices before market availability," the authors write.

Explore further: Most high-risk cardiac devices in use today approved as modifications to previously-approved devices

More information: Abstract
Full Text (subscription or payment may be required)

Related Stories

Most high-risk cardiac devices in use today approved as modifications to previously-approved devices

January 21, 2014
The Food and Drug Administration (FDA) ensures that high-risk medical devices, such as implantable cardioverter-defibrillators and pacemakers, are safe and effective through its premarket approval (PMA) pathway, during which ...

Most newly approved biologics studied in peds population

January 15, 2013
(HealthDay)—The majority of biologics approved since 1997 include pediatric information in their labeling and have been studied in pediatric trials, according to a review published online Jan. 14 in Pediatrics.

US approves first heart pump for children

December 18, 2011
The US Food and Drug Administration has approved a first mechanical cardiac assist device for children that can help keep patients alive as they await a transplant.

Patient safety merits new review for modified medical devices, physician says

March 25, 2014
For patient safety, the U.S. Food and Drug Administration (FDA) should require that clinical data be submitted as part of a more rigorous re-evaluation of medical devices that are modified after approval, according to UC ...

Children continue to be underrepresented in drug trials

July 23, 2012
(HealthDay) -- Even for conditions with a high pediatric disease burden, only a small proportion of clinical drug trials study pediatric patients, according to research published online July 23 in Pediatrics.

Portable vision screening devices accurately identify vision problems in young children

October 25, 2013
Portable screening devices allow pediatricians to successfully screen children for vision problems, including amblyopia, according to an abstract presented Oct. 25 at the American Academy of Pediatrics (AAP) National Conference ...

Recommended for you

At the cellular level, a child's loss of a father is associated with increased stress

July 18, 2017
The absence of a father—due to incarceration, death, separation or divorce—has adverse physical and behavioral consequences for a growing child. But little is known about the biological processes that underlie this link ...

New comparison chart sheds light on babies' tears

July 10, 2017
A chart that enables parents and clinicians to calculate if a baby is crying more than it should in the first three months of its life has been created by a Kingston University London researcher, following a study of colic ...

Blood of SIDS infants contains high levels of serotonin

July 3, 2017
Blood samples from infants who died of Sudden Infant Death Syndrome (SIDS) had high levels of serotonin, a chemical that carries signals along and between nerves, according to a study funded in part by the National Institutes ...

Is your child's 'penicillin allergy' real?

July 3, 2017
(HealthDay)—Many children suspected of being allergic to the inexpensive, first-line antibiotic penicillin actually aren't, new research indicates.

Probiotic supplements failed to prevent babies' infections

July 3, 2017
(HealthDay)—Probiotic supplements may not protect babies from catching colds or stomach bugs in day care, a new clinical trial suggests.

Starting school young can put child wellbeing at risk

June 22, 2017
New research has shown that the youngest pupils in each school year group could be at risk of worse mental health than their older classmates.


Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.