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How to Prepare a 510(k) Submission In Vitro Diagnostic (IVD) Devices Definition In vitro diagnostics are medical devices that analyze human body fluids, such as blood or urine, to provide information for the diagnosis, prevention, or treatment of a disease. The device classification for these devices can be found under 21 CFR 862, 21 CFR 864, and 21 CFR 866. Labeling In Vitro Diagnostic Products have special labeling requirements and distribution restrictions under 21 CFR 809, In Vitro Diagnostic Products for Human Use. Additional guidance can be found under "Device Advice Labeling Requirements for In Vitro Diagnostic Devices." Clinical Laboratory Improvement Amendments (CLIA) of 1988 In addition to FDA regulation under the Food, Drug, and Cosmetic Act, in vitro diagnostic (IVD) devices are also subject to the Clinical Laboratory Improvement Amendments (CLIA) of 1988. This law established quality standards for laboratory testing and an accreditation program for clinical laboratories. The requirements that apply vary according to the technical complexity in the testing process and risk of harm in reporting erroneous results. The regulations established three categories of testing on the basis of the complexity of the testing methodology: waived tests, tests of moderate complexity, and tests of high complexity. Laboratories performing moderate- or high-complexity testing or both must meet requirements for proficiency testing, patient test management, quality control, quality assurance, and personnel. These specific requirements do not apply to tests in the waived category. In January 2000 the categorization of commercially marketed in vitro diagnostic tests under CLIA was tranferred from the Center for Disease Control and Prevention (CDC) to FDA. CDRH's Office of of In Vitro Diagnostic Device Evaluation and Safety (OIVD) determines the appropriate complexity categories for clinical laboratory devices as they evaluate premarket submissions. Waived products, devices exempt from premarket notification, and devices under premarket review by other FDA Centers are also processed by OIVD. Responsibilities currently assigned to CDC, including review of test systems, assays, or examinations not commercially marketed as IVD products, will remain with CDC. Below is a list of CLIA Program Information Resources: FDA CLIA Website (complexity
categorizations, waiver) CMS CLIA Website (program
information, statistics, etc.) CDC CLIA Website (regulations,
CLIAC) Additional information on assignment of CLIA categories by FDA can be found on the Internet at http://www.fda.gov/cdrh/clia/ Additional IVD Guidance For additional information on in vitro diagnostics devices, please visit the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) website at http://www.fda.gov/cdrh/oivd/ Medical devices reviewed by the Center for Biologic, Evaluation, Research The Center for Biologic, Evaluation, Research (CBER) has expertise in blood, blood products, and cellular therapies as well as the integral association of certain medical devices with these biological products. To utilize this expertise marketing and investigational device submissions (Premarket Notification, Premarket Approval, and Investigational Device Exemption) for medical devices associated with the blood collection and processing procedures as well as those associated with cellular therapies are reviewed by CBER. Although these products are reviewed by CBER, the medical device laws and regulations still apply. The list of medical devices reviewed by CBER are available on the Internet http://www.fda.gov/cber/dap/devlst.htm Additional guidance on medical devices reviewed by CBER can be found at http://www.fda.gov/cber/devices.htm or contact: Center for Biologics Evaluation
and Research Third Party Review Program The Center for Devices and Radiological Health (CDRH) has implemented a Third Party Review Program. This program provides an option to manufacturers of certain devices of submitting their 510(k) to private parties (Recognized Third Parties) identified by FDA for review instead of submitting directly to CDRH. For more information on the program, eligible devices and a list of Recognized Third Parties go to Third Party Review Program Information page.
Reference: www.FDA.gov The information provided here is for "public consumption" and is open to interpretation. MedicalDeviceSchool.com is not responsible for the content or the accuracy of the information. For all official interpretation and accuracy we ask that you consult the FDA's website directly and that you consult with your legal and regulatory experts on all matters of interpretation. |
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