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Change Expectations > Change Technology > Change Healthcare The Medical Device "Plug-and-Play" (MD PnP) Interoperability Program is promoting innovation in patient safety and clinical care by leading the adoption of secure patient-centric integration of medical devices and IT systems in clinical environments. |
Medical Device Interoperability Safety Working Group (MDISWG)
| QUICK LINKS > CIMIT > TATRC > NIH/NIBIB > MD PnP White Paper > ICE Standard (ASTM F2761) > MD FIRE RFI & RFP ............................................ BECOME A MEMBER > Benefits of Membership > Membership Application ............................................ CONTACT INFORMATION MD PnP Program 65 Landsdowne St., Suite 200 Cambridge, MA 02139 info@mdpnp.org Julian M. Goldman, MD Program Director jgoldman@mdpnp.org Drayton Freeman Program Assistant dwfreeman@mgh.harvard.edu |
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 "presubmission") for Interoperable Medical Devices
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.
Update May 14, 2014: Pre-Submission supplement Q140327 for an Integrated Medical Device System and MDISWG Introduction document are now publicly available at http:////img1.wsimg.com/blobby/go/74e3adad-c06b-4df3-958d-b12a5eaa7f21/downloads/MDISWG_Cover_letter_and_FDA_Pre-Submission_I120162_Supplemen.pdf
The documents are licensed under Creative Commons Attribution 4.0.
Update August 2015: 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)