AMIA Supports FDA Commitments for MDUFA IV

Wednesday, November 2, 2016

Informatics experts see Digital Health, NEST as next frontier for policy development and public-private collaboration

(BETHESDA, MD) — In conjunction with a public meeting held today, the American Medical Informatics Association (AMIA) submitted comments supporting the direction of FDA’s Medical Device User Fee Amendments, known as MDUFA IV, which was published in late October. The nation’s biomedical informaticians view policy development around the formation of a National Evaluation System for health Technology (NEST) and a framework for Digital Health, as critical areas to focus in the coming months.

During today’s meeting, officials from the FDA’s Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) discussed proposed performance goals and procedures to assure more timely access to safe and effective medical devices. The MDUFA IV commitment letter, produced as the result of long negotiations with regulated industry, will dictate how user fees are spent to improve the safety, effectiveness and efficiency of device reviews.

Specifically, AMIA supports FDA’s commitments to enhance use of consensus standards; develop patient engagement strategies and improve the science of patient input; utilize real world evidence (RWE) to improve regulatory decision-making and in support of a National Evaluation System for health Technology (NEST); and development of a policy framework for Digital Health, which includes Software as a Medical Device (SaMD) and Software inside of Medical Devices (SiMD).

“Historically, AMIA has not engaged with FDA over its priorities for medical device review,” the organization said in comments. “However, recent FDA musings on evidence generation, along with several recent guidance documents, signal clear interest by the Administration to leverage informatics tools and methodologies to augment regulatory decision-making. We fully support these efforts and believe AMIA members are well-positioned to help FDA realize the tremendous value of real world data to inform medical device reviews and surveillance.”

The development of a National Evaluation System and formation of a policy framework for Digital Health are among the more interesting aspects of MDUFA IV, and will require strong collaboration among policymakers, industry, patients and researchers, AMIA said. “The merging of software and medical devices is a truly exciting, and somewhat daunting, area for policy development. We fully support this development and offer our members’ informatics expertise to help FDA supplement its competencies in this space.”

The full MDUFA IV letter can be viewed here


AMIA, the leading professional association for informatics professionals, is the center of action for 5,000 informatics professionals from more than 65 countries. As the voice of the nation’s top biomedical and health informatics professionals, AMIA and its members play a leading role in assessing the effect of health innovations on health policy, and advancing the field of informatics. AMIA actively supports five domains in informatics: translational bioinformatics, clinical research informatics, clinical informatics, consumer health informatics, and public health informatics.