By Stewart Eisenhart, Emergo Group
EMERGO SUMMARY OF KEY POINTS:
- Summary Technical Documentation (STED) was developed to drive more standardization of medical device regulatory submissions across markets.
- STED is recognized by US, European, Canadian, Australian and Japanese regulators, as well as in other markets.
- The International Medical Device Regulators Forum (IMDRF) has been planning updates to the STED format, but there is little progress to report thus far.
Without proper formatting, the most meticulously researched and prepared medical device market application can fail to pass regulatory review, costing the applicant time and money. In many of the world’s largest medical device markets, regulators prefer Summary Technical Document, or STED, formatting for approval and registration submissions.
Which regulators use STED?
The STED format was created by the Global Harmonization Task Force (GHTF), the precursor to the current International Medical Device Regulators Forum (IMDRF), in an effort to globally standardize medical device regulatory submissions.
Regulators from five major markets—the US, the European Union, Canada, Australia and Japan—are currently either actively using STED or evaluating the format under pilot programs. Canadian regulators, for example, strongly recommend STED formatting for Class III and IV Medical Device License (MDL) submissions, while the Japanese Pharmaceutical and Medical Devices Agency (PMDA) essentially requires STED formatting for market authorization applications.
STED components
For the most part, STED resembles documentation required for European Technical Files. Although STED’s current iteration is still based on a years-old GHTF document, the IMDRF has tasked one of its working groups with updating the format, but progress has been slow.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.
The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.
