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* You are viewing Posts Tagged ‘CDRH’

Looking for the FDA Accession Number Database? It Doesn’t Exist so Read This Carefully

admin November 13, 2012 Law & Regulatory, Medical Devices No Comments

Tags: accession number, CDRH, contact, customs form 2877, database, detainment, electronic, emitting, FDA, imports, law, look up, products, radiation, shipment, united states

FDA Accession Number Database Lookup

If you distribute or import radiation-emitting electronic products, you may have already heard of FDA’s accession number system.  However, we have found that many importers are perplexed when they are required complete Customs Form 2877 which, in part, asks the importer to supply an accession number if the imported product is subject to FDA performance standards.  “Where can I look up the accession numbers for my products?” is a very common question we receive at this point in the importation process.  The answer is … READ MORE

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FDA Clarifies its Concerns about Medical Devices from Japan

admin June 03, 2011 Law & Regulatory, Medical Devices No Comments

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

FDA Medical Device RegulationIn 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

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