The FDA announced Wednesday that it will begin implementing the 2007 legislation requiring medical device companies to include information on pediatric populations in certain pre-market applications.

Companies will have to provide information on pediatric demographic groups that suffer from the disease or condition that the medical device is meant to "treat, diagnose or cure, even if the device is intended for adult use," according to the FDA.

Pediatric patients are patients who will need use of the device at age 21 or younger, and currently, there are very few devices that are manufactured with children in mind.
"Our reason for being is to bring about the commercial application of drugs and devices for pediatric care," says Ross Trimby, COO for the non-profit Institute for Pediatric Innovation. "[The legislation] is good news because it will mean more device manufacturers will decide to attempt to sell those devices for pediatric application."

Not only must manufacturers provide information on the pediatric sub-population that would use the device, they must also include the number of affected pediatric patients.

Trimby points out that these requirements could actually help device companies bring in more revenue.

For example, a company could say, "when I look at the numbers [of affected pediatric patients], maybe if I did this change to [the device], we could sell our similar technology in terms of this application and do more business," Trimby posits.

While not all devices can be tweaked to cater to pediatric patients (and some devices need to be made especially for children) many devices can still perform some procedures on adults while also being used for younger patients; an example is catheters, says Trimby.

Tim Moran, the CEO of PediaWorks, an organization that helps with the development of pediatric medical devices, says he hopes this legislation will at the very least least make manufacturers aware of the lack of pediatric medical devices.

Some medical device companies "assume the pediatric market is too small, and they can't justify the investment to make a pediatric device," Moran says. "Hopefully this legislation will guarantee that they will take a deeper dive into the pediatric market."

Tara Federici, the vice president for technology and regulatory affairs for the Advanced Medical Technology Association (AdvaMed), said the company is unable to comment until its analysis of the rules is complete.

"AdvaMed and its members recognize the importance of ensuring that pediatric patients have access to life-saving and life-enhancing medical devices," she says. "We are committed to working with the FDA and providers to identify and characterize the unmet medical technology needs for pediatric patients."

According to an FDA statement, the rule is scheduled to go into effect August 16, unless there is significant adverse commentary, which is required to be filed by June 15.

More Industry Headlines