Objectives and Mechanisms of Global Regulatory Harmonization Melissa

Objectives and Mechanisms of Global Regulatory Harmonization Melissa Torres, MBE, MSE Associate Director, International Affairs (Acting) Office of the Center Director Center for Devices and Radiological Health melissa. torres@fda. hhs. gov 1

Disclosures • None 2

Mechanisms of Global Harmonization • Harmonization by Doing (HBD) – Japan and US • International Medical Device Regulators Forum (IMDRF) – Australia, Brazil, Canada, China, Europe, Japan, Russia, and US • Sharing of public and non-public information among regulators around the world 3

Harmonization by Doing • Use of internationally agreed upon standards for global clinical trials for cardiovascular devices. • Developed by FDA, Japanese regulators, academia, and industry in order to promote timely medical device approvals in both countries. 4

IMDRF Mission The mission of the International Medical Device Regulators Forum (IMDRF) is to strategically accelerate international medical device regulatory convergence to promote an efficient and effective regulatory model for medical devices that is responsive to emerging challenges in the sector while protecting and maximizing public health and safety. 5

IMDRF Strategic Plan • Enhance Post-Market Surveillance; and • Improve the Effectiveness and Efficiency of Pre-Market Review. 6

IMDRF Current Work Items • Adverse Event Terminology – Improve, harmonize and where necessary expand the terminology and systems being used to code information relating to medical device adverse events. • Good Regulatory Review Practices – Develop one set of common competence and training requirements for premarket reviewers to promote regulatory convergence. 7

IMDRF Current Work Items • Software as a Medical Device (Sa. MD) – Support innovation and timely access to safe and effective Sa. MD globally by identifying commonalities, establishing a common vocabulary, and developing approaches for appropriate regulatory controls that promote regulatory convergence. • Patient Registries – Develop shared essential principles of informatics infrastructure and best epidemiologic and statistical analytic methodologies to enhance the quality, speed and cost-efficiencies of regulatory science for medical 8 devices.

IMDRF Current Work Items • National Competent Authority Report (NCAR) – Facilitate the exchange of relevant post market safety information on medical devices with global distribution in order to trigger rapid adoption of field safety corrective actions in all concerned geographies to avoid death or serious deterioration of health, when relevant. • Medical Device Single Audit Program (MDSAP) – Establishment of a single audit program for assessing medical device manufacturers. 9

IMDRF Current Work Items • Regulated Product Submission (RPS) – Define a common ‘Table of Contents’ for medical device regulatory submissions as a first step in defining a common data set for regulatory submissions. 10

Sharing of Information with Global Regulators • FDA has confidentiality commitments with numerous FDA counterparts in foreign countries and international organizations allowing for the sharing of certain kinds of non-public information as part of regulatory activities. – Share public and non-public information on issues such as trends, adverse events, recalls, inspections, guidance documents, panel meetings, etc. • Allows regulators to leverage resources, aggregate data, and share information for better informed 11 regulatory policies and decisions.

Summary Sharing information and working in partnerships globally to address issues of mutual interest and concern ultimately allows patients timely access to safe, effective, and high-quality medical devices. 12

Thank You 13