Medical Device Interoperability Safety Working Group (MDISWG)
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.
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)