The new FDA requirement that’s described in this press release is a bit odd.

As of now, the FDA requires that “manufacturers now must include a description of any pediatric subpopulations that suffer from the disease or condition that the device is intended to treat, diagnose, or cure. Manufacturers also must include the number of affected pediatric patients.”

Lemme make sure I understood this… the FDA wants to know what diseases and conditions a manufacturer’s product is designed to treat? And a real quantifiable number of how many kids are affected by the disease that their product intends to treat?

Hmmm.

The press release also says… “Very few devices are developed or assessed specifically for use in pediatric patients, those 21 or younger at the time of treatment or diagnosis. 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. The requirements, contained in the Food and Drug Administration Amendments Act of 2007, 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.”

Anything that tries to fly under the banner “we’re doing it for the kids” is an automatic suspect in my book.

Is there anything wrong with this request? Not that I can see. But is it a strange request? Most definitely.

Here’s the official FDA press release on the new requirement.