Originally Published MDDI April 2005
NEWSTRENDS
Pilot Program for Submission Format Extended
CDRH has decided to extend a pilot program for submitting applications in a new harmonized format.
Under the program, certain PMA and 510(k) filings can be submitted in the Summary Technical Document (STED) format. The Global Harmonization Task Force (GHTF), an industry-government partnership spanning five nations, developed the new format. If it gains acceptance, the form of device submissions across the globe could eventually be standardized.
CDRH initiated its pilot program in June 2003 and announced in February that it will be extended through July 2006. The center is strongly encouraging device manufacturers to use the format. It says manufacturers seeking international clearance for their products will benefit from early exposure to the STED preparation projects. In addition, FDA wants its reviewers to become familiar with STED submissions and to be able to provide constructive feedback to GHTF.
Guidance on the STED format can be found on-line at www.fda.gov/cdrh/ode/guidance/1347.html. Manufacturers should consult that document before submitting anything in the format. More guidance for STED preparation can be found on-line at the GHTF Web site at www.ghtf.org/sg1/ sg1-proposed.html.
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