The regulatory approval process for biomaterials for treating skin loss - Biomaterials for Treating Skin Loss - page 101

7.5 The Global Harmonization Task Force (GHTF)

The Global Harmonization Task Force (GHTF) was formed in 1992. 26 This task
force consists of the European Union, United States of America, Japan, Australia
and Canada. The GHTF was formed in an effort to harmonize regulations globally.
As medical devices become more complex and technologically advanced, the
regulations governing these products also must change and become more adept at
the review and regulation of these devices to assure safety and effectiveness.
Review of the quality systems that manufacture these complex products and the
postmarket surveillance also become more complex. At the same time, efforts
must be made to allow these products to be available for the advancement of patient
care and treatment. The GHTF provides a forum for both regulators and repre-
sentatives from the medical device industry to address complex issues.
The harmonization of the review process includes clinical trial data and equally
important quality system requirements. This chapter concentrates on the regula-
tions of the United States of America and the European Union. However, the
medical device and pharmaceutical market is highly regulated all over the world.
The goal is to provide a unified global regulatory model to harmonize regulations.

7.5.1 Summary technical documentation (STED)
The summary technical documentation (STED) is a harmonized submission
format developed by the (GHTF). STED was intended to be a standard, harmo-
nized format accepted by multiple regulatory agencies globally. The details of the
format and documentation required are outlined in the GHTF document Summary
Technical Documentation for Demonstrating Conformity to the Essential Princi-
ples of Safety and Performance of Medical Devices (STED) . 27
The United States Food and Drug Administration initiated a voluntary pilot
premarket review program using the STED in June, 2003. FDA's guidance
document A Pilot Program to Evaluate a Proposed Globally Harmonized Alterna-
tive for Premarket Procedures details 28 the documents and format for the STED
are detailed in this guidance document. The FDA must be contacted first to
determine if the premarket submission can be made in the STED format.
The STED contains documentation that is an expanded version of documents
required in a design dossier submission for Class III medical devices under the
European Union Medical Device Directive and FDA Premarket Approval applica-
tion. 3

7.6 Quality system

The quality system which includes the manufacturing process is integral to the
approval process in the USA, the European Union and almost every other country.
In the USA, if the product is a medical device subject to the PMA or a