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U.S. Department of Health and Human Services

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FY 2004 ODE Annual Report - Part 4 - Major Program Initiatives

 Division Tracking System (DTS)

The Division Tracking System (DTS) is a web-based tracking system which allows easy entry and access to file information and serves as a mechanism to evaluate MDUFMA performance. It is designed to track the progress of a document through the review process and thus assist the Office of Device Evaluation (ODE) and the Office of In Vitro Diagnostic Device Evaluation and Safety (OVID) in managing documents and review projects in order to measure, monitor and/or meet MDUFMA, office, division, or branch goals. The system allows performance of the same functions as the earlier document tracking systems but provides user the abilities such as generating of individual reports, organizing, searching and viewing files. The new system provides additional capabilities in a web-based environment. It is designed to supplement, not replace, the data already existing in the POS databases. Additionally, the current Division Tracking System (DTS) allows the OVID to measure, monitor and/or meet Clinical Laboratory Improvement Amendments (CLIA) issues and Office of Combination Products (OCP) to track Request For Designation (RFD) documents.

 ODE/DRARD/Epi Pilot Project

As part of ODE’s effort to formalize Total Product Life Cycle precepts within the premarket review process, the Division of Reproductive, Abdominal, and Radiological Devices (DRARD) continued their pilot cooperative project with the Epidemiology Branch (EB) of the Office of Surveillance and Biometrics. The purpose of the project is 1) to determine when and how the EB could best provide appropriate input/recommendations to DRARD regarding potential postmarket investigations and 2) to initiate, and later evaluate, product-specific Postmarket Plans. The epidemiologists continue to participate in the review of PMAs being evaluated by DRARD. Two of the PMAs that were approved during the year had post approval studies. In both cases the epidemiology reviewer played a large role in the study design. Both groups believed that the involvement of the EB in the PMA review enhanced the review process. All participants believed that early involvement was the best approach, with “early” now being defined as beginning at the time of the filing meeting. Both groups believed that there was not enough experience gained in the first two years of the pilot and that continuing the pilot would allow for further refinement of the process. Therefore the decision was made to continue the pilot project over the next year.

 30-Day Notice Program

In accordance with section 515(d)(6) of the Federal Food, Drug, and Cosmetic Act, PMA applicants are required to submit 30 day Notices for changes to manufacturing procedures or methods of manufacture that affect the safety and effectiveness of the device. Historically, 30-day notices have been jointly reviewed by both ODE and OC. The official letter accepting/rejecting the Notices was signed by ODE, because the OC did not have the regulatory authority to sign official PMA letters. Because of this joint effort, there is a delay in sending the decision letter to the PMA applicant. To make this process more efficient, the regulation was revised to provide OC division directors the authority to sign 30 day Notices/135-day Supplements. Since the expertise for reviewing manufacturing information and determining compliance with QSR belongs to OC, it is most appropriate to have OC assume full responsibility for conducting these reviews, making final decisions, and signing off on 30-Day Notices and 135-Day PMA/HDE/PDP Supplements for Manufacturing Method or Process Changes.