FY 2004 ODE Annual Report - Part 6 - Program Support
Freedom of Information Requests
ODE Vendor Day
Other Than Hiring to Expand/Enhance Resources Program (OTHER)
Medical Device Web Home Page
Computer Tracking Systems
Electronic Shared Workplace
Processing Premarket Applications
ODE staff received 972 FOI requests during FY04, an increase from 512 in the last fiscal year. During FY04, the number of FOI requests closed was 547 compared to 836 in FY03. The total number of FOI requests pending in ODE at the end of FY04 is 587 compared to 207 in FY03.
Staff from ODE responded to Congressional inquiries and participated in briefings on the following topics -- breast implants, electromagnetic treatment devices, automatic external defibrillators, menstrual cups, accreditation of radiology facilities, microderm abrasion machine, liquid oxygen, x-ray screening for asbestos, motor cortex, chair lift, and condoms. ODE also participated in hearings of Congressional committees and briefings of Congressional staff during FY 04. These topics dealt with FDA's budget and labeling of condoms.
During FY04, ODE staff authored 19 manuscripts for publication in professional and scientific journals and delivered 105 presentations at professional, scientific and trade association meetings. See Appendix B for a bibliography of publications.
On October 23, 2003 , ODE sponsored a vendor day on heart valve devices. Companies represented included Metronic, St. Jude Medical, Edwards Lifesciences, and Centerpulse Cardiac Division/Carbomedics. Several vendor days are being planned for FY05.
In FY04, 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 firms and/or hospitals were visited by 128 scientific reviewers to learn about such things as hearing aids, lasers or aesthetic procedures, heart failure clinical procedures, endosseous implants, anesthesia ventilators, vaporizers and nitric oxide delivery devices, antimicrobial coating applications, tissue heart valves, heart valves, bone void filler/bone cements, retinal implants, aberrometry and visual optics, thoracic stent-grafts, intraocular lenses and various ophthalmic implants, 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’s effort to increase the hiring of minorities and those with a disability, ODE participated in the 2004 Marriott Bridges Students with a Disabilities Program. In addition, ODE participated in several other recruiting fairs including: the 2004 Miami Diversity Career Fair, 2004 Blacks in Government Career Fair and the 2004 Hispanic Reporter’s Hispanic Career Fair, 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 2004 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 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 95 hours of training per employee in 2004. 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
In FY 04, ODE received 48 complete electronic copies of submissions for PMAs, IDEs, Pre-IDEs and 510(k)s from 16 different sponsors in addition to the paper submission. These numbers show a decrease from FY 03 when 97 complete submissions were received from 25 different sponsors. Prior contact with an ODE 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.
ODE continues 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. 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 can be found on the ODE home page under Medical Device Approvals.
CDRH 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 FY 04, ODE held 5 video conferences with industry, Federal agencies and with the US Army.
The primary work performed in FY 2004 was the development of the new Division Tracking System (DTS). This new web-based application was designed to provide more effective tracking of premarket submissions. The project deliverables included prototyping sessions, data entry revisions, data migration, user training, standard and user-generated reports, a user’s guide and documentation. Also, there were various levels of effort to integrate DTS with other Center applications and this effort will continue in FY 2005. In addition to this application, considerable work was done in reconciling 510k and PMA user fee data.
ODE installed medical/pharmaceutical/dental/biotech spell checking software on all of the ODE computers to assist in the preparation of review-related documents. ODE continued to install docking laptops to enable reviewers to use the same computer at work and at home with all files available at both locations. In addition, ODE increased the number of users working from home and continued to provide training and equipment for offsite access to the FDA network.
The CDRH system for storing electronic copies of device application submissions was upgraded to provide additional capabilities for ODE reviewers. The new system now stores documents in Portable Document Format (PDF), the Agency's standard, and allows for full text searching, for copying or saving documents and for printing all or part of the submission. The system has been so well received that in FY04 ODE began the task of scanning over 2200 boxes of past IDE and PMA paper submissions currently stored at an offsite warehouse into the system making the data electronic, searchable and easily retrievable from the reviewers desktop.
In FY04, ODE piloted the use of web-based software to facilitate communication and interactions among team members in the review of PMAs. The software was used with all new PMAs and PMA supplements for specific branches in ODE and with other specific PMAs from non-pilot branches. A software template and the rules for using the software were developed by a cross-center team including representatives from ODE and several of the offices involved in the review of PMAs. The results of the pilot will be assessed to determine whether the template will be rolled out CDRH-wide for PMA reviews. The software is also used by groups within ODE for collaboration, document creation, and document posting in a shared work space.
Since the passage of FDAMA and MDUFMA, there is a definite need to optimize and modernize CDRH premarket administrative processes and the supporting IT architecture and systems. A Center-wide group is identifying current inefficiencies in the processing of Premarket Applications and will develop improved procedures that will be phased in on a prioritized basis.
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 users ability to avoid risk, achieve maximum benefit, and make informed decisions about the use of such products.
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