Same Submission Form for Different Nations in Pilot Program

Originally Published MDDI November 2003

NEWSTRENDS

James Dickson
Erik Swain

In an effort to harmonize the review process, device companies will be able to submit the same forms to multiple nations for evaluation of certain devices under a new pilot program.

CDRH will assess the feasibility of using an internationally harmonized format to review submissions for medical device safety and performance, Office of Device Evaluation director Dan Schultz said in September. Called the STED initiative (for Summary Technical Documentation for Demonstrating Conformity to the Essential Features of Safety and Performance of Medical Devices), the program derives from a Global Harmonization Task Force (GHTF) report. 

Schultz said the pilot will be limited to certain PMA applications and 510(k) notification submissions, and initially does not include in vitro diagnostics. Examples of devices eligible for the program are identified in a guidance at http://www.fda.gov/cdrh/ode/guidance/1347.pdf. FDA said it will consider adding device types to the list if industry so requests, and is looking to have a sample of submissions over a broad range of devices.

The GHTF is encouraging manufacturers to use the “draft STED document” in submissions to as many participating countries as possible. These include the United States, Canada, Australia, the European Union, and Japan. Each GHTF member country is free to conduct the pilot program within its own jurisdiction, so some device types may not be eligible for the program in all nations.

FDA said in the guidance that its analysis of the pilot program will consider whether there are significant impediments to filing and reviewing STED documents, whether the STED format is useful for evaluating different classes of devices, and whether use of STED improves regulatory review times. The agency is not making any promises that the latter will occur, and is telling those interested in the pilot to expect review times to remain equivalent. 

Manufacturers interested in participating in the program, or who have questions, should contact Harry R. Sauberman, PE, 301/443-8879, [email protected], or Eric J. Rechen, 301/ 594-2186 ext. 138, ejr@cdrh. fda.gov. 

Copyright ©2003 Medical Device & Diagnostic Industry