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Zdrowie i gospodarka · 15.05.2002

Combination Products Containing Live Cellular Components; Public Hearing

The Food and Drug Administration (FDA) is announcing a public hearing to discuss the jurisdictional classification, assignment, and premarket review of certain products that consist of living human cells in combination with a device matrix. The hearing will focus on products that are intended for wound healing (e.g., wound repair or skin regeneration, replacement, or reconstruction), although the information obtained may also be pertinent to questions concerning other combination products containing live cells. Combination products that include human cell or tissue components have significant potential to enhance the public health. The purpose of the hearing is to solicit information and views from interested persons, including scientists, clinical investigators, professional groups, trade groups, commercial enterprises, and consumers, on the issues and concerns relating to the premarket review and regulation of these combination products. To assist in the development of a consistent policy on jurisdiction for these products, FDA is interested in responses to specific questions and any other pertinent information stakeholders would like to share.

Source: Federal Register — Food and Drug AdministrationOpen original release →