Devices

CDRH International Harmonization Plan

FDA has issued a draft Center for Devices and Radiological Health (CDRH) International Harmonization Strategic Plan. A CDRH statement (contains a link to the draft plan) says the plan “includes specific strategies to directly encourage harmonization, convergence, and reliance among medical device regulatory authorities, as applicable, and builds on the work CDRH is currently doing with international stakeholders.” The strategic plan’s objectives are to:

strengthen diplomatic relations that promote alignment in best practices and inform risk-based decision-making; and
encourage harmonization, convergence, and reliance among international regulatory authorities and other stakeholders.

The plan describes how CDRH will meet several MDUFA 5 commitments specific to international harmonization.

“CDRH recognizes that successful international harmonization will require the integration of ideas and perspectives from key stakeholders, including other regulatory authorities, industry, conformity assessment bodies, patients, standards development organizations, and internal CDRH staff,” the plan says. “CDRH appreciates that we are one of many stakeholders, with one of many perspectives. This plan is rooted in an inquiring outlook that recognizes not only the expertise CDRH may be able to provide others, but, equally, the expertise and learnings that other stakeholders may be able to provide CDRH.”

During the next four years, the plan says, CDRH looks forward to strengthening existing diplomatic relationships that are critical to risk-based decision-making using the most up-to-date scientific and regulatory intelligence, as well as furthering broader work on harmonization, convergence, and reliance.

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