FY 2003 ODE/OVID Annual Report - Part 6 - Program Support
Staff from ODE and OIVD received 512 FOI requests during FY 03, a decrease from 739 in the last fiscal year. During FY 03, the number of FOI requests closed was 836 compared to 1,141 in FY 02. The total number of FOI requests pending in ODE and OIVD at the end of FY 03 is 207 compared to 345 in FY 02.
Staff from ODE and OIVD responded to Congressional inquiries and participated in briefings on the following topics -- user fees, breast implants, dental amalgam, plano contact lens, contact lenses, temporomandibular joint implant or TMJ, bovine spongiform encephalopathy or BSE, the Medical Device User Fee and Modernization Act of 2002 or MDUFMA, electromagnetic treatment devices, and condoms. ODE and OIVD also participated in hearings of Congressional committees and briefings of Congressional staff during FY03. These topics dealt with FDA's budget, counter terrorism, human tissue, dental amalgam, and FDA's efforts to combat the SARS outbreak.
During FY 03, ODE staff authored 33 manuscripts for publication in professional and scientific journals and delivered 103 presentations at professional, scientific and trade association meetings. See Appendix B for a bibliography of publications.
OIVD staff authored 6 manuscripts for publication and delivered 18 presentations. See Appendix C for a bibliography of publications.
In FY 03, ODE did not schedule any Vendor Days.
In FY 2003, ODE continued its Site Visit Program that was developed in 1993 to enhance reviewer knowledge of how specific medical devices are designed, manufactured, and tested. The program continued to include not only visits to medical device manufacturing firms but also to hospitals for the observation of certain devices in use. Twenty-one firms and/or hospitals were visited by 194 scientific reviewers to learn about such things as laser refractive surgery, di Vinci robotic system, left ventricular assist device, catheters, anesthesiology, breast implants, vascular stents, MR-guided focused ultrasound ablation of uterine fibroids, antimicrobial testing for new surface modification, cardiac electrophysiology devices, spinal implants, fecal incontinence devices, ophthalmic contrast sensitivity, and other devices.
ODE’s mentoring program is designed to orient new employees to their job responsibilities and their workplace. The program matches a new employee with a mentor who is expected to provide technical, informational and career guidance to the employee in an effort to enable employee assimilation into the workforce and to ensure appropriate employee development. The ODE PMO Office has served as an informal mentoring agent for minorities.
To enhance the Center effort to increase the hiring of minorities and those with a disability, ODE participated in the 2003 Workforce Recruitment Program (WRP) for College Students with Disabilities and the Marriott’s Bridges Program. In addition, ODE participated in several other recruiting fairs including: the FDA’s 2003 Presidential Management Intern Job Fair; 2003 FDA Science Forum Job Fair; and the Department’s Emerging Leaders Program, just to name a few.
In an effort to enhance and expand resources for the Office of Device Evaluation, the Program Management Office continues to use a variety of methods through the OTHER initiative. Some of the OTHER programs that were utilized in FY 2003 include:
ORISE – Oak Ridge Institute for Science and Education –provides educational appointments for students, faculty, teachers, and post graduates at various FDA-approved host facilities; ODE Employee Exchange – useful for bringing employees from other FDA and CDRH offices into ODE for short periods; Experts/Consultants - intermittent temporary services of highly qualified people who possess unique professional, scientific, or technical expertise that is not available within the regular workforce; Contracts - arrangements that can be used to acquire services not available in the existing workforce and for short-term needs that require specific skills; ODE Intern Program - a no-cost program that brings students and professionals to ODE for short-term work experience; ODE Employee Share Program - an employee from one division works part-time or full-time for a limited period of time in another division within ODE or at another Office within the Center; ODE University Partnership Program (UPP) - partnership with medical schools to allow their students an opportunity to observe and learn the FDA medical device product approval process while assisting reviewers.
ODE employees attended many courses, lectures, and grand rounds sponsored by the CDRH Staff College. They also attended local colleges and various off-site training institutions, and availed themselves of a multitude of other training opportunities associated within their field of expertise (e.g., meetings, seminars, workshops). ODE employees averaged 138 hours of training per employee in 2003. Supervisors continued to participate in monthly meetings to discuss current management issues, and all employees attended all-hands meetings to learn about new program polices and procedures.
Significant work was done to the document tracking systems for the 510k, PMA, and Modular PMA data bases. New hold statuses were created and the data entry programs were modified to check MDUFMA payment status and to apply holds automatically. MDUFMA payment data was linked to the 510k, PMA, and PMR data entry programs and new programs were written to notify CDRH staff of payments received. A new flag was added to the 510k and PMA tracking systems for the STED Initiative. The Sted Initiative is a pilot program to assess the feasibility of using an internationally harmonized format in the review of certain submissions for device safety and performance.
ODE and OIVD continued to improve their desktop computer equipment with the installation of new desktop computers, and the upgrade of all desktop computer operating systems to Windows 2000 professional. ODE and OIVD prepared its staff to meet the FDA secure remote access requirements by providing training and equipment for offsite access to the FDA network.
A joint ODE/OIVD team worked with other Center employees involved in the PMA review process to develop procedures for an electronic shared workplace that will make the PMA review process more efficient. This will be done using web-based software that enables distributed teams to work together. It is hoped that this tool will facilitate collaborative review by increasing information dissemination among team members and will assist in fostering best business practices.
In FY 03, ODE received 97 complete electronic copies of submissions for PMAs, IDEs, and 510(k)s from 25 different sponsors in addition to the paper submission. These numbers show an increase from FY 02 when 73 complete submissions were received from 14 different sponsors. Prior contact with an ODE or OIVD division is still requested before developing and sending an electronic copy. Electronic copies enhance the efficiency of the review process, especially when several CDRH offices are involved in the review of the submission. Instructions for submitting submissions in electronic form can be found on the CDRH home page at the address http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ HowtoMarketYourDevice/PremarketSubmissions/ucm134508.htm.
CDRH has the ability to conduct Room and Desktop Video Conferences with outside parties that have H.320 compliant systems, a standard for video conferencing over ISDN lines and other narrowband transmission media. In FY 03, ODE held 8 video conferences were held involving industry and other Federal agencies.
ODE and OIVD continue to provide information on the web that can be downloaded and searched through the ODE home page at http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHOffices/ucm115879.htm and through the OIVD home page at http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/default.htm. Information on Premarket Approval Applications (PMAs) and Premarket Notifications (510(k)s) can be found on the ODE home page. Information about recent device approvals in ODE and OIVD can be found on the ODE home page under Medical Device Approvals and on the OIVD home page under All Cleared/Approved OIVD Products.
The CDRH system for storing copies of past device application submissions was upgraded to provide additional capabilities for ODE/OIVD reviewers. Reviewer input played a major role in the redesign of the document repository and the upgraded system has been well-received. The system now stores documents in PDF format and allows for full text searching, for copying or saving documents and for printing all or part of the submission.
The Consumer Staff in FDA’s Center for Devices and Radiological Health, Division of Small Manufacturers, International and Consumer Assistance (DSMICA) also provides information to consumers regarding medical devices and radiation-emitting products to enhance their ability to avoid risk, achieve maximum benefit, and make informed decisions about the use of such products.
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