Harmonized Submission Format for Medical Device Firms Proposed
Wouldn't it be great to launch your next product globally? It certainly makes good business sense. But for medical device manufacturers, this is an unreasonable goal because different countries and geographical regions require different regulatory submission formats. So, a 510(k) that has been cleared by the FDA is not applicable in Australia or France because of unique format requirements in those countries. What this means is that a medical device firm's schedule for product release must be handled on a country-by-country basis.
The good news is that the FDA's Summary Technical Document (STED) Pilot Program may finally bring the elusive goal of global launch within every medical device manufacturer's reach. The FDA's Center for Devices and Radiological Health (CDRH) is encouraging firms submitting premarket approval (PMA) and premarket notifications or 510(k)s to participate in the voluntary STED pilot program.
Participants will be using the STED format, a harmonized submission format developed by the Globalization Harmonization Task Force (GHTF). The group is a voluntary partnership of government and industry representatives from the United States, Australia, Canada, the European Union, and Japan. Founded in 1992, GHTF has promoted standardization of global regulatory practices by issuing almost 40 harmonized guidances, now widely followed by many countries.
The STED pilot program is expected to continue indefinitely until CDRH receives a sufficient number of STED-formatted applications to be able to make a conclusive evaluation of the suitability of the submission format.
Why join the pilot program? Here are four major benefits:
In summary, if you could compile a single submission that satisfies the regulatory bodies in each of the world's major medical device markets, why wouldn't you? Companies desiring to participate should refer to the FDA Web site for more information and program contacts.
About the AuthorMatthew M. Lowe, a product manager at MasterControl Inc., is a mechanical engineer with almost a decade of experience as a product development engineer and a product manager in the medical device industry.