This year FDA chairs the International Medical Device Regulatory Forum. Regulators form around the world (Australia, Brazil, Canada, China, Europe, Japan, Russia and USA) will gather in San Francisco to work towards accelerating international medical device regulatory harmonization and convergence.
Their focus this year will be:
1) Standalone Medical Device Software Harmonization (SaMD)
2) NCAR system (exchange of relevant post market safety information)
3) Roadmap for implementation of UDI (uniform device identification)
4) Medical Device Single Audit Program (MDSAP)
5) IMDRF recognized standards
6) Regulated Product Submission (in electronic format)
This is an opportunity for FDA's vision of "Patients in the U.S. have access to high-quality, safe, and effective medical devices of public health importance first in the world"to be broadened.
It is my experience that FDA staff are some of the most dedicated stewards of public health and I think everyone would easily agree that it is in the best interest of the global human race that all patients have access to safe and effective medical devices as soon as they are available.
Since most industrial nations are facing the medical needs of their growing aging population, having the most expedited access to medical devices also makes fiscal sense. By developing a single set of standards with which to access global markets, companies could potentially have lower cost and burden to access all of their markets. This could potentially change the current paradigm of companies basing their decision to market a medical device on the affordability of each countries specific regulatory and trade requirements.
It is also a time to move forward with caution. With the boon of Health Information Technology, clinical information becomes more accessible. The need to make informed decisions often drives the desire to require more information which can easily drive up costs for medical devices to demonstrate safety and effectiveness. The balance that needs to be struck is the efficiency to access the right data for intelligent decisionsSM.
-- Vizma Carver, Founder and CEO, Carver Global Health Group