US FDA Updates Electronic System for Medical Device Exporters

The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has updated its voluntary electronic system for requesting medical device export documents based on feedback from manufacturers and initial importers.

Through the CDRH Export Certification and Tracking System (CECATS), medical device manufacturers seeking to export their products from the US can obtain Certificates to Foreign Governments (CFG) as well as certificates of exportability covered by the Federal Food, Drug & Cosmetic Act faster than by submitting written requests for such documents. By 2015, the CDRH plans to enable electronic requests for export permit letters, simple notifications and non-clinical research-only certificates on CECATS.

Companies must have an account with the FDA Unified Registration and Listing Systems (FURLS) in order to access CECATS. The FDA will offer CECATS training webinars to cover recent system updates.

Stewart Eisenhart

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