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The STED Initiative: Bringing the Global Community Closer to Harmonization

 The FDA is reminding device manufacturers of the Summary Technical Document (STED) format submissions.  Such formats are ideal for manufacturers that end up submitting device documentation in multiple countries. 

 Developed by the Global Harmonization Task Force (GHTF) a manufacturer can compile one set of documentation using the STED format and use it to submit to United States, Health Canada and the European Union and other countries.  This can potentially cut down the amount of work that is required to address the particular requirements for all those regions.

In the United States the FDA has recognized the benefits and have recently extended the program to July 2006.  Under the program both 510(k)s and PMAs can take advantage of the program.  The FDA hopes that as more and more STEDs are prepared and submitted, it’s popularity will increase.

Ironically at the time this articles was being written, there have been no submitted STEDs issued to the Therapeutic Products Directorate (TPD)¹.  It is unclear if this is in fact the case or if Health Canada has simply not updated their site.  In all circumstances the governments have responded to industry requests to standardize the documentation it’s only a matter of time before the industry responds.

In Canada the program is open to Class III and IV devices.  Which makes sense since the program has most to benefit the manufacturer at the two class levels. The TPD has specifically granted the go ahead for the following devices:

• Intravascular catheters
• External Infusion Pumps
• Endosseus Dental Impants
• Hemodialyzers and Hemodialysis Catheters
• Plamsa Cell Separators for Therapeutic Use
• Bone Densitometer X-ray
• Fluoroscopic X-ray
• Urological Catheters
• ECG Monitors

Here are some links you will find useful if you decide to go STED:

Global Harmonization Task Force

http://www.ghtf.org/sg1/sg1-proposed.html

Health Canada

http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/ghtf_sted_guide_e.html

USA

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