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US FDA to ISO13485 open the door
Medical device companies to sell medical devices to the United States must comply with the corresponding quality system requirements, that is, 21 CFR 820 (or QSR, or QSR, Quality System Regulation). The US Food and Drug Administration (FDA) will review medical devices outside the United States from time to time in accordance with the requirements of 21 CFR 820. If a failure is detected, a warning is issued.
Many Chinese companies meet the ISO 13485 quality system requirements, but suffer from the same time need to comply with the US FDA's 21 CFR 820 regulatory requirements. In recent years, the industry asked the US FDA to gradually accept and move closer to the ISO 13485 increasingly high. Recently the FDA will start a new program to open the door to ISO 13485.
The US Food and Drug Administration (FDA) will begin a new pilot program in June 2012 to allow medical device manufacturers the opportunity to obtain a one-year lead after submitting ISO13485: 2003 quality system audits to the US Food and Drug Administration Year of the US FDA 21 CRF 820 quality system inspection exemption.
Currently, the US FDA requires all medical device manufacturers in the US and abroad to meet the requirements of the 21 CFR 820 (also known as FDA GMP) quality system. Allowing companies the opportunity to submit ISO 13485 audit results to obtain a one-year US FDA quality system audit exemption, the move will allow the FDA to further the global medical device regulations to coordinate the guidance of organizations close.
Any medical device manufacturer within the United States or abroad may participate in the pilot program and submit the audit results to the FDA within 90 days of obtaining the ISO 13485 audit results. In addition, audit reports issued by ISO 13485 auditors to medical device manufacturers must comply with the GHTF Founding Membership Regulations. If the US FDA reviewers believe that the ISO 13485 audit report is acceptable, the FDA will allow the manufacturer to remove from the US FDA routine checklist within a year of the most recent ISO 13485 audit date.