Major Elements of a Submission

Major elements of a submission can be found by browsing the Office of In Vitro Diagnostic Devices and Safety (OIVD) 510(k) data templates posted on the OIVD Web page [6] . These summarize information related to specific cleared products, including the intended use/indications for use, analytical and clinical validation information, device description including platform and software information, information on instrument and software validation when applicable, and labeling (package insert information). IVD labeling is unique among medical devices since it is described specifically in regulation [21 CFR 809.10(b)]. For PMAs, information describing manufacturing, design controls, and adherence to quality system regulations are also needed.

The intended use should specify what analyte the test measures, the clinical indication for which the test is to be used, and the target population for which the test is intended. It should also indicate whether the test is qualitative and quantitative.

Analytical validation includes precision (repeatability and reproducibility), accuracy, limit of detection, interferences, cross- r eactivity, software, performance around the cutoff, carryover, cross hybridization, sample preparation/ conditions, and assay limitations. FDA recognizes dozens of standards by the Clinical Laboratory Standards Institute (CLSI) to assist companies in developing this information. A list of recognized standards [10] may also be found on the OIVD Web page.

Clinical validation should be established in appropriate clinical studies to support the indication for use and claims of the device. These studies generally need to be provided by the sponsor or, if available, sponsors may also cite applicable clinical literature. For clinical literature to be acceptable for product clearance or approval, the quality must be carefully assessed and the link between the published studies and the device being reviewed must be carefully established. In instances where tests are developed based on sequential use of training sets followed by independent test validation, the FDA encourages that rigorous and meticulous attention be paid to the training sets used for new diagnostic markers. However, FDA review is focused on the independent validation that supports the merits of the device itself based on feasibility studies and development of a clear hypothesis in a defined population under established conditions of use.

When the system includes software, software documentation including software design, hazard analysis, and complete verification and validation should be provided [11]. Labeling needs to be detailed sufficiently to satisfy the requirements of 21 CFR 807.87(e). Final labeling for in vitro diagnostic devices must comply with the requirements of 21 CFR 809.10 before the device is introduced into interstate commerce. Among the particularly important components of required labeling are an intended use, device description, directions for use, quality control, precautions, warnings and limitations, performance characteristics, interpretation of results, and values expected.

Project Management Made Easy

Project Management Made Easy

What you need to know about… Project Management Made Easy! Project management consists of more than just a large building project and can encompass small projects as well. No matter what the size of your project, you need to have some sort of project management. How you manage your project has everything to do with its outcome.

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