FDA Clarifies its Concerns about Medical Devices from Japan
Tags: animal electrical, CBER, CDRH, Center for Biologic Evaluation and Research, Center for Device and Radiological Health, compliance, detention, documentation, drug, earthquake, exporters, FDA, food, import, inspection, inspections, japan, laboratory, medical devices, mold, regulation, regulatory, safety, sterile, sterilization, temperature control, testing, united states, violations, water
In a previous FDAImports.com article on the Japan Earthquake it was stated that FDA-regulated products from Japan will likely face many new hurdles in order to enter the United States. FDA will likely subject them to greater regulatory review by inspecting incoming food, drugs and medical devices and possibly subjecting them to laboratory testing.
On June 1, 2011, the Center for Device and Radiological Health (“CDRH”) and the Center for Biologic Evaluation and Research (“CBER”) issued a … READ MORE
