![]() This guidance document identifies the classification regulation and product code for RNA collection, stabilization, and purification systems. A manufacturer who intends to market a device of this generic type should (1) conform to the general controls of the Federal Food, Drug, and Cosmetic Act (the Act), including the premarket notification requirements described in 21 CFR 807 Subpart E, (2) address the specific risks to health associated with the device identified in this guidance, and (3) obtain a substantial equivalence determination from FDA before marketing the device. ![]() If, however, you believe that there is a less burdensome way to address the issues, you should follow the procedures outlined in The Least Burdensome Provisions: Concept and Principles: Guidance for Industry and FDA Staff.įDA believes that special controls, when combined with the general controls, will be sufficient to provide reasonable assurance of the safety and effectiveness of a RNA preanalytical system. We believe that we have considered the least burdensome approach to resolving the issues presented in the guidance document. ![]() We also considered the burden that may be incurred in your attempt to follow the statutory and regulatory criteria in the manner suggested by the guidance and in your attempt to address the issues we have identified. In developing the guidance, we carefully considered the relevant statutory criteria for Agency decision-making. The issues identified in this guidance document represent those that we believe need to be addressed before your device can be marketed. The firm must show that its device addresses the issues of safety and effectiveness identified in this guidance, either by meeting the recommendations of this guidance or by some other means that provides equivalent assurances of safety and effectiveness. However, the firm need only show that its device meets the recommendations of the guidance or in some other way provides equivalent assurances of safety and effectiveness. Any firm submitting a premarket notification (510(k)) for a RNA preanalytical system will need to address the issues covered in this special controls guidance document. This guidance is issued in conjunction with a Federal Register notice announcing the classification of RNA preanalytical systems. It also may contain instruments for automation of the nucleic acid isolation and purification steps. The device may consist of sample collection devices, nucleic acid isolation and purification reagents, and processing reagents/equipment (tubes, columns, etc.). RNA preanalytical systems are devices intended to collect, store, and transport patient specimens, and stabilize intracellular RNA from the specimens, for subsequent isolation and purification of the intracellular RNA for RT-PCR (real-time polymerase chain reaction) used in in vitro molecular diagnostic testing. This guidance document was developed as a special controls guidance to support the classification of RNA preanalytical systems (RNA collection, stabilization and purification systems) into class II (special controls). THE CONTENT AND FORMAT OF AN ABBREVIATED 510(K) SUBMISSIONĬlass II Special Controls Guidance Document: RNA Preanalytical Systems (RNA Collection, Stabilization and Purification Systems for RT-PCR used in Molecular Diagnostic Testing) Please use the document number (1563) to identify the guidance you are requesting. Additional CopiesĪdditional copies are available from the Internet. You may also send an e-mail request to to receive an electronic copy of the guidance or send a fax request to 30 to receive a hard copy. Comments may not be acted upon by the Agency until the document is next revised or updated. When submitting comments, please refer to Docket No. Alternatively, electronic comments may be submitted to. Written comments and suggestions may be submitted at any time for Agency consideration to Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852. Office of In Vitro Diagnostic Device Evaluation and Safetyĭivision of Immunology and Hematology Devices Department of Health and Human ServicesĬenter for Devices and Radiological Health
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