Making sense of the Food and Drug Administration

• Published in: Seminars in pediatric surgery Vol. 15; no. 4; pp. 293 - 301
• Main Author: Connor, Jessica Anne
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.11.2006
• Subjects: Altruism; Center for Device and Radiological Health (CDRH); Child; Device Approval - legislation & jurisprudence; Equipment Design - classification; Equipment Design - instrumentation; Equipment Design - standards; Equipment Safety - instrumentation; Equipment Safety - standards; Food and Drug Administration (FDA); Humanitarian use device (HUD); Humanitarian use device exemption (HDE); Humans; Investigation device exemption (IDE); Pre-market approval (PMA); Pre-market notification (510(k)); Surgical Equipment - classification; Surgical Equipment - standards; Surgical Instruments - classification; Surgical Instruments - standards; United States; United States Food and Drug Administration - legislation & jurisprudence; United States; Pre-market notification (510(k)); Pre-market approval (PMA); Center for Device and Radiological Health (CDRH); Food and Drug Administration (FDA); Humanitarian use device (HUD); Humanitarian use device exemption (HDE); Investigation device exemption (IDE)
• ISSN: 1055-8586; 1532-9453
• DOI: 10.1053/j.sempedsurg.2006.07.009

An examination of and recommendations regarding the approval process for medical devices are presented. The typical pathways and hurdles laid out by the Federal Food and Drug Administration (FDA) are discussed, and options for marketing and use of medical devices are addressed. The first step in the regulatory process is to establish that the new product is, in fact, a medical device. From there, the appropriate classification and the corresponding level of regulatory control that will be required can be identified. The appropriate marketing application will be submitted and is supported by the data necessary to reasonably assure safety and effectiveness. Once the application is submitted, reviewed, and eventually approved, the manufacturer may legally market and sell the medical device. The active involvement of physicians as advisors and innovators in medical device development is imperative to the successful development of safe and effective medical devices. Physicians also fulfill the important obligation of adverse event reporting with all medical devices that they use. The pediatric physician should additionally be aware of the FDA regulations and expectations with respect to devices that will serve pediatric patient populations, of the regulatory options for approval and unapproved use for some devices, and of the special measures taken to protect the rights, safety, and welfare of pediatric patients participating in investigational studies.