FY 2002 ODE Annual Report - Part 6 - Program Support
Freedom of Information Requests
ODE Vendor Day
Computer Tracking Systems
Medical Device Web Home Page
ODE staff received 739 FOI requests during FY 02, a decrease from 868 in the last fiscal year. During FY 02, the number of FOI requests closed was 1,141 compared to 1,048 in FY 01. The total number of FOI requests pending in ODE at the end of FY 02 is 345 compared to 420 in FY 01.
ODE staff responded to inquiries and participated in briefings on such topics as single use devices, breast implants, Medicare/Medicaid coverage issues, plano contact lens, on-site drug testing, CLIA, potassium iodide, biomedical life systems, electromagnetic devices, electrical stimulation devices, low frequency radiation, and tooth preparation instruments. ODE also participated in Congressional hearings held during FY02 dealing with FDA's budget, reuse of medical devices labeled for single use, and user fees.
During FY 02, ODE staff authored 9 manuscripts for publication in professional and scientific journals and delivered 88 presentations at professional, scientific and trade association meetings. See Appendix B for a bibliography of publications.
In FY 02, ODE, in conjunction with the Association of Medical Diagnostics Manufacturers (AMDM) sponsored a Vendor Day. This was an informative exhibit and exchange seminar with two device manufacturers of Diagnostic and Safety Devices comprised from four different groups to show different device areas: Diagnostics Systems, Injection and Infusion Therapy Business – safety products, Preanalytical Solutions – safety blood collection devices, and Biosciences. The Vendor Day was very successful with attendance from over 100 FDA employees.
In FY 2002, 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-three firms and/or hospitals were visited by 156 scientific reviewers to learn about such things as innovative surface modifications, implantable middle-ear hearing aids, knee resurfacing, heart valves, 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 in the hiring of minorities and those with a disability, ODE participated in the 2002 Excellence in Government Conference; HHS Department Recruitment Fair; and the Department’s Emerging Leaders Program.
ODE continues to increase its use of a variety of methods to improve its resources. In FY 2002, they included:
- 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 with their field of expertise (e.g., meetings, seminars, workshops). ODE employees averaged 108 hours of training per employee in 2002. 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.
ODE tracking system changes included premarket database enhancements, revised report and query programs, and modifications to the division-level tracking system. One enhancement involved a field that was added to the division tracking system to capture the receipt of an electronic submission and to enable the consistent reporting of electronic submissions. Programming commenced on the effort to insert a field in the tracking systems to record the submission of applications representing a combination product. The reporting capability was greatly enhanced by automating the data compilation effort needed to prepare the ODE annual report.
During Fiscal Year 2002 ODE supported a number of software installations on its desktop PCs to provide a more current operating environment. Hardware improvements continued with the purchase of PCs and laptops and with the installation of Blackberry wireless handheld devices for senior management and individuals involved in special support activities. ODE reviewers helped to test and provide comments on the new document archival system (Image2000) which is slated to replace the original Image system initially developed in 1989. The ODE Intranet homepage was developed to serve as a portal to information needed by ODE employees.
In Fiscal Year 2002, ODE received 73 complete electronic submissions for PMAs, IDEs, and 510(k)s from 14 different sponsors. These numbers show a steep decline from FY01 because ODE revised its definition of an electronic submission for Fiscal Year 2002 to indicate that the entire submission arrive at ODE in an electronic format. ODE plans to expand its electronic submission effort in FY03 and will share its plans with the regulated industry. Prior contact with an ODE division is still requested before developing and sending an electronic submission. Instructions for submitting electronic submissions can be found on the FDA home page.
ODE has the ability to conduct 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 Fiscal Year 2002, 5 video conferences were held involving industry and other Federal agencies.
ODE continues to provide information on the web that can be downloaded and searched through the CDRH home page at http://www.fda.gov/MedicalDevices/default.htm. Information on Premarket Approval Applications (PMAs) and Premarket Notifications (510(k)s) can be found on the CDRH home page under Device Program Areas/Device Evaluation Information. Information about new medical device approvals can be found on the device evaluation home page at http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHOffices/ucm115879.htm. This page was redesigned in FY02 to consolidate links to information and to simplify the search for device-related information.
Center for Devices and Radiological Health (CDRH) maintains searchable databases of devices previously approved for marketing or declared substantially equivalent to a legally marketed device at http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ DeviceApprovalsandClearances/default.htm#databases.
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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