Medical Device Interoperability Safety Working Group (MDISWG)
The MD PnP Program has had ongoing projects to clarify the regulatory pathway for integrated medical device and HIT systems.
Project: FDA Pre-IDE (now called a "Pre-Submission" or "Q-Sub") for Interoperable Medical Devices
As follow-up to the FDA workshop on Medical Device Interoperability held in January 2010, the Prototype Regulatory Submission Working Group formed (with approximately 20 participants from industry, clinicians, standards development organizations, and the FDA), and met via weekly MD PnP program hosted teleconferences from 2010 through 2011 to develop a detailed risk model for a conceptual integrated medical device system, intended to allow the FDA and interoperability stakeholders to identify and address regulatory science issues related to interoperability.
In the Spring of 2012, the group provided the analysis to date to the FDA, and continued to meet as a sub-group without the FDA, re-named as as the Medical Device Interoperability Safety (MDIS) Working Group to create a Pre-IDE submission (now called a Pre-Submission). The MDIS Working Group meetings resulted in industry consensus on the architecture contained in the ASTM ICE standard as desirable for the Pre-submission, which was submitted to the FDA in February 2012, and discussed in a productive face-to-face meeting in April 2012.With preliminary agreement from the FDA on the core approach of this submission, it was further refined and a Supplement was submitted in March 2014. The MDISWG expects to continue researching safety issues for systems of integrated medical devices and HIT. This project has been supported in part by NIH grant 1U01EB012470.
Update May 14, 2014: Pre-Submission/Q-Sub supplement Q140327 for an Integrated Medical Device System and MDISWG Introduction document are now publicly available at http://mdpnp.org/uploads/MDISWG_Cover_letter_and_FDA_Pre-Submission_I120162_Supplement.pdf
The documents are licensed under Creative Commons Attribution 4.0.
The MDISWG has almost completed a response to FDA questions on the Pre-Submission supplement. Check back for an updates.
(Contributors to Pre-submission supplement are listed in the document)