High-risk medical devices, children and the FDA: regulatory challenges facing pediatric mechanical circulatory support devices.

Full Abstract

Pediatric mechanical circulatory support is a critical unmet need in the United States. Infant- and child-sized ventricular assist devices are currently being developed largely through federal contracts and grants through the National Heart, Lung, and Blood Institute (NHLBI). Human testing and marketing of high-risk devices for children raises epidemiologic and regulatory issues that will need to be addressed. Leaders from the US Food and Drug Administration (FDA), NHLBI, academic pediatric community, and industry convened in January 2006 for the first FDA Workshop on the Regulatory Process for Pediatric Mechanical Circulatory Support Devices. The purpose was to provide the pediatric community with an overview of the federal regulatory process for high-risk medical devices and to review the challenges specific to the development and regulation of pediatric mechanical circulatory support devices. Pediatric mechanical circulatory support present significant epidemiologic, logistic, and financial challenges to industry, federal regulators, and the pediatric community. Early interactions with the FDA, shared appreciation of challenges, and careful planning will be critical to avoid unnecessary delays in making potentially life-saving devices available for children. Collaborative efforts to address these challenges are warranted.

Learn Faster Today Improve your study skills

Author information

Author/s: Almond, Christopher S D (CS); Chen, Eric A (EA); Berman, Michael R (MR); Less, Joanne R (JR); Baldwin, J Timothy (JT); Linde-Feucht, Sarah R (SR); Hoke, Tracey R (TR); Pearson, Gail D (GD); Jenkins, Kathy (K); Duncan, Brian W (BW); Zuckerman, Bram D (BD);

Affiliation: Department of Cardiology, Children's Hospital Boston, Harvard Medical School, Boston, Massachusetts 02115, USA.

Journal and publication information

Publication Type: Journal Article

Journal: ASAIO journal (American Society for Artificial Internal Organs : 1992) (ASAIO J), published in United States. (Language: eng)

Reference: -2007 Jan-Feb; vol 53 (issue 1) : pp 4-7

Dates: Created 2007/01/22; Completed 2007/02/01; Revised 2007/11/15;

PMID: 17237642, status: MEDLINE (last retrieval date: 12/26/2008)

Sourced from the National Library of Medicine. Abstract text and other information may be subject to copyright.

External Links for this article (including full text providers, if available):

Click Electronic Full-text Provider Links to see options for finding the electronic full text links to this article. Note there may be a subscription or fee required for access to the full text. See our FAQ for information on finding FREE full text articles.

This article may also be located in paper journal collections available in many libraries. Use the Journal and Publication Information above to find the full article.

MeSH headings (categories)

This article was linked to the MESH Headings shown below.

Humans
Sample Size
United States
United States Food and Drug Administration

These are the highest related articles currently in the database:

See 100+ related articles.