MRC Comments on FDSIA Report
MRC comments on the Food and Drug Administration Safety and Innovation Act (FDASIA) Health IT Report: Proposed Risk Based Regulatory Framework (the “FDASIA Report”).
MRC FDASIA Comments (July 3, 2014)
Policy Positions & Comments
MRC Accessory Policy White Paper
MRC Accessory Policy White Paper (July 3, 2014)
MRC White Paper: Consumer Medical Devices Used To Manage Health
MRC Consumer Medical Devices Used to Manage Health White Paper (July 3, 2014)
MRC Comments to the IMDRF Proposal
Comments to “Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Controls”
MRC Letter to Rep. Blackburn on Proposed HIT Legislation
On July 12, the MRC sent a letter to Rep. Blackburn on Proposed HIT Legislation. Read the MRC’s position here.
MRC Position on MMA Final Guidance Publication
The mHealth Regulatory Coalition (MRC) believes FDA should publish its final guidance on mobile medical apps as soon as reasonably possible. The timely release of the final guidance will benefit industry, stimulate investment, help ensure patient safety and is consistent with the views expressed by Congress and the mHealth community. Read the MRC’s position here.
MRC Testimony Before the House Energy and Commerce Committee, Subcommittee on Communications and Technology
mHealth Regulatory Coalition testified at House Energy and Commerce Hearing
Earlier this week Bradley Merrill Thompson testified on behalf on the mHealth Regulatory Coalition in front of the House Energy and Commerce Subcommittee on Technology and Communications. He joined other witnesses calling for the FDA to release its final guidance on medical mobile apps as soon as possible. Read the press release here.
House Energy & Commerce Subcommittee on Communications & Technology Testimony
MRC Issue Brief: Software Modularization
Issue Brief: Software Modularization— FDA Falling Behind on the Regulation of Reusable Software