Guidance for Industry and Staff – Pilot Program to Evaluate Proposed Globally Harmonized Alternative for Premarket Procedures

The FDA on Nov 10, released Guidance on the voluntary premarket review program - Summary Technical Documentation (STED pilot). The guidance was originally issued in the Federal Register on June 26, 2003.

The STED Pilot is being implemented by the CDRH and is limited to Premarket Approval (PMA) and 510(k) submissions. The program will assess the feasibility of a proposed internationally harmonized format and content for receiving PMA and 510(k) applications. The guidance provides a list of device types that will be considered for submission under this program. However, device classes that are not mentioned in list will be considered on a case-by-case basis. The “Draft STED document” (this is the common name, actually title on document is quite long!) should be referenced to submit applications under this program. Manufacturers should consult with the FDA to find out if they are eligible to participate in this pilot program.

FDA plans to keep the pilot active until the agency has received adequate number of submissions to evaluate the program.

For more details on this guidance, please refer to: http://www.fda.gov/cdrh/ode/guidance/1347.pdf

The draft STED document can be viewed at: http://www.ghtf.org/sg1/inventorysg1/pd_sg1_n011r17.pdf

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