Emir Galevi, Justina Tam, a technical expert from U.S. Food and Drug Administration (FDA) visited BACL lab and had a friendly technical exchange on May 20, 2019. During the meeting, FDA conducted in-depth analysis on the FDA certification requirements of laser products, microwave products and X-ray products and the quality control requirements of factories.FDA technical expert here emphasizes:

FDA requires that not only the samples need to meet the 21st cfr1020/21 cfr1030/21 cfr1040, the U.S. federal regulatory requirements, but also each product exported to the United States shall conform to the federal regulation requirements. Therefore, FDA factories need to set up a sound IQC product quality control system for incoming material inspection, production process inspection, preshipment inspection and other inspections of different processes.

BACL not only can provide you with the FDA's products Report and Annual Report service, but also can provide you with customized FDA inspection counseling service. BACL technical experts will visit your factory, help your factory to fully meet the FDA certification and FDA factory quality control requirements on all production and inspection processes, ensure that your products can pass inspection and be exported to USA market smoothly!

Summary of FDA Certification Standards for CDRH Radiation Products

For more information about FDA certification, please feel free to contact BACL technical experts. We will give you a timely and accurate reply by confirming with FDA, ensuring your products’ smooth entry into the North American market!

BACL Service:

BACL has been dedicated to North American certification for 22 years. It is the NRTL safety certification body recognized by OSHA, the safety certification body recognized by Canada SCC, the U.S. FCC TCB certification body, and the U.S. Energystar CB certification body. BACL can provide our client with one-stop and comprehensive testing and certification services on FCC, NRTL, FDA, Energystar, DLC, DOE, CE, CB, PSE, SAA, CEC, CEC Title20, CEC Title24, FTC, CPSC and CA65, etc. Welcome to contact us!