Pediatric medical devices: a look at significant US legislation to address unmet needs

Abstract

There are many barriers to the availability of medical devices intended for the pediatric population causing healthcare providers to use creative measures to address pediatric unmet device needs. The USA has taken significant legislative measures to spur medical device development and address the unmet needs in all pediatric subpopulations. For example, the Medical Device User Fee and Modernization Act of 2002 amended the Federal Food Drug and Cosmetic Act by adding new provisions intended to promote the development of safe and effective pediatric devices, and to protect the pediatric population during clinical trials. In 2004, the Medical Devices Technical Corrections Act was added to address potential difficulties in bringing pediatric devices to the market. Further, the Pediatric Medical Device Safety and Improvement Act of 2007 and the Food and Drug Administration Amendments Act of 2007 provided the FDA significant new responsibilities and authorities regarding pediatric use.

Keywords::

• FDA
• medical devices
• pediatric
• pediatric population
• pediatric subpopulation
• unmet needs
• US legislation

Disclaimer

This article only reflects the authors’ views on this subject and not the pediatric medical device goals or regulatory agenda of the US FDA.

Financial & competing interests disclosure

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending or royalties.

No writing assistance was utilized in the production of this manuscript.

Key issues

• Multiple areas of unmet medical device needs have been identified in the pediatric population, including, but not limited to, the following: catheters, intubation tubes, cardiovascular devices, surgical instruments, diagnostic devices as well as radiologic and imaging devices.

• Several landmark laws have been enacted in the USA to facilitate improvement and development of pediatric medical devices. These have provided significant incentives to spur development and availability of medical devices for the pediatric population.