- Guidance for Industry and Reviewers
Significant Jurisdictional Issues Involving Devices in FY 2000
Advisory Panel Activities
ODE Integrity Program
Freedom of Information Requests
ODE Vendor Day
Other Employee Programs
Computer Tracking Systems
World Wide Web Activity
In FY 00, ODE published 25 final guidance documents and published 5 draft guidance documents for comment. See INDUSTRY INFORMATION for a complete listing of all ODE guidance documents published in FY 00.
The FDA Modernization Act of 1997 contains a charge to FDA to require only clinical data or information necessary to establish device effectiveness or to confer substantial equivalence. FDA must consider the least burdensome means of demonstrating effectiveness or equivalence in the review of premarket applications. Pursuant to this congressional mandate, ODE has taken the lead in implementing the concept of "least burdensome." As part of this effort, ODE actively participated in a CDRH-wide working group on least burdensome issues. As part of the efforts to implement the least burdensome provisions of FDAMA, ODE's internal tracking documents and correspondence with companies have been modified to highlight least burdensome efforts. Working collaboratively with an Industry Task Force, ODE participated in the preparation of a draft "Concepts and Principles" document. Efforts are continuing, both internally and with the Industry Task Force, to implement the least burdensome provisions in all of our activities. Information related to the least burdensome provisions of the FDA Modernization Act of 1997 can be accessed on the CDRH website.
Title 21 of the Code of Federal Regulations Part 3 - PRODUCT JURISDICTION describes the procedure the agency uses to assign Center jurisdiction over medical products whose jurisdiction is not clear or is in dispute. Requests for Designations (RFDs) over such products are made in writing to the FDA Office of the Chief Mediator and Ombudsman. These formal submissions contain the material describing the requester's product and their proposal regarding which Center should be given the lead designation over the product and whose authorities (Biological, Device or Drug) should apply.
In FY 2000, CDRH participated in the review of 21 out of 23 RFDs (two were assigned wholly to CDER and CBER only) in addition to completing the review of 2 RFDs received in FY 99. The reviews of the 21 new requests were assigned to the ODE Divisions as follows; DGRND was assigned to review seven and shared an additional review with DOED, DDIGD and DCRD were assigned five each, DOED was assigned one and shared one with DGRND, and DCLD was assigned one RFD. Finally, one was not assigned to any division as it was handled by the Center’s coordinator for incoming RFDs.
Out of the 21 RFDs assigned to CDRH for review, seven were not due for completion until FY 2001. Of the 16 RFD’s whose reviews were completed, CDRH was assigned the lead center in 10 of those requests and one was withdrawn before its review could be completed. Of the remaining five the lead center designation was to either CDER or CBER.
The Center's Medical Devices Advisory Committee (MDAC) provides advice to FDA on the safety and effectiveness of marketed and investigational devices, the classification of devices into one of three regulatory categories, the possible risks to health associated with the use of devices, the formulation of product development protocols, the review of premarket approval applications, and the content of guidelines or guidance documents designed to improve the interaction between the Agency and sponsors of medical devices. The MDAC consists of 18 panels divided according to medical device specialties.
In FY 00, ODE held 27 panel meetings, 12 open meetings and 15 partially closed. Of the 18 panels, four met at least once, four met twice, and five met three times during the fiscal year. The panels collectively considered 28 PMA submissions, five PMA Supplements, four Reclassifications, two PDPs, one 510k, and two guidance documents. The panels discussed and provided advice on a number of issues. Topics ranged, for example, from the design of clinical trials to support claims for reduced posterior capsular opacification for intraocular lenses, devices used in atrial fibrillation therapies, to assessing the performance of in vitro diagnostic tests for hepatitis infection. Further information about government-wide advisory committees is available at the Federal Advisory Committee Act Database.
There were 25 formal training sessions for new panel members (special government employees known as SGEs). The two-hour training for SGEs covered the laws and regulations with respect to medical devices, organizational structure of the Agency, ODE's operations, the roles and responsibilities of panel members, the elements of a panel meeting, and conflict of interest.
Panel members are leading authorities in a broad range of medical areas and have current experience in medical practice, teaching and/or research. Each panel has a consumer representative, an industry representative, and when appropriate, a patient representative; these panel members do not vote but provide valuable input into panel discussions. Patient representatives served on two panels during the fiscal year – the Clinical Chemistry and Clinical Toxicology Devices Panel meeting on December 6 and 7, 1999, and the Neurological Devices Panel on March 31, 2000. During the past fiscal year, females made up 43% of the ODE panel membership and minorities approximately 31%.
ODE continuously recruits highly qualified experts to serve as consultants and panel members. Potential candidates are asked to provide detailed information concerning financial holdings, employment, and research grants and contracts to identify any potential conflict of interest. Interested individuals should send their resume to the Advisory Panel Coordinator, Office of Device Evaluation, 9200 Corporate Boulevard, Rockville, Maryland 20850.
Announcements of panel meetings are publicized in several ways: voice information via the FDA Advisory Committee Information Line (1-800-741-8138), printed information in the Federal Register, and on the Internet (http://www.fda.gov/AdvisoryCommittees/default.htm). This website also includes summaries of the most recent advisory panel meetings.
The Guidance on Amended Procedures for Advisory Panel Meetings was revised on July 22, 2000, to clarify the standard operating procedures that apply to advisory panel meetings where a specific submission is being considered by the panel or to device classification panel meetings on issues involving more than one sponsor. The clarification addresses timeframes for when and what types of information/new data analyses might be submitted to the panel. The revised guidance is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ GuidanceDocuments/ucm073722.htm.
During this fiscal year, ODE investigated about 62 cases concerning the integrity of data submitted to the agency in premarket applications. Under the Application Integrity Program (AIP), two firms were placed on the AIP list and AIP restrictions applied against these firms.
ODE handled 37 instances related to questions arising under the standards of conduct for employees. During FY 00, as in years past, the ODE staff received several unsolicited gifts from the regulated industry. Both the offering of gifts and their acceptance in general, are prohibited under applicable laws and regulations. The regulated industry, their agents and representatives should not send gifts to staff members. (See Standards of Ethical Conduct for Employees of the Executive Branch on the internet at http://www.usoge.gov/ethics_docs/publications/reference_publications/rfsoc_02.pdf).
ODE staff received 1,080 FOI requests during FY 00, a decrease from 1,355 last fiscal year. During FY 00, the number of FOI requests closed was 1,146 compared to 834 in FY 99. The total number of FOI requests pending in ODE at the end of FY 00 is 621 compared to 771 in FY 99.
Congressional interest in ODE programs continued to be strong in FY 00. ODE staff responded to inquiries and participated in briefings on such topics as hearing aids, breast implants, drug test kits, dental amalgam/illness, hemodialysis, and reuse. ODE also participated in Congressional hearings held during FY 00 dealing with FDA’s budget, FDAMA, reuse, and genetic testing.
During FY 00, ODE staff authored 20 manuscripts for publication in professional and scientific journals and delivered 58 presentations at professional, scientific and trade association meetings. See Appendix B for a bibliography of publications.
In FY 00, ODE, in conjunction with the regulatory industry, sponsored one Vendor Day - an informative exhibit and exchange seminar with device manufacturers on cardiovascular, general and restorative, clinical laboratory and other devices.
In FY 00, ODE continued its Site Visit Program that was developed 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 hospitals for the observation of certain devices in use. As a result, 11 firms and/or hospitals were visited to learn about orthopedic products, blood-glucose products, endovascular grafts, dialysis systems, IVD products, condoms, and other devices.
ODE employees attended many courses, lecturers, and grand rounds sponsored by the CDRH Staff College. Supervisors continued to participate in monthly meetings to discuss current management issues, and all employees attended all-hands meetings to learn about new FDAMA polices and procedures.
ODE sponsored three in-house training courses for employees and managers: Media Relations Workshop, Congressional Hearings Workshop and Interviewing Techniques.
ODE continues to improve and enhance its mentoring program. The program is designed to orient new employees to their job responsibilities and their workplace. The program matches new employees with a mentor who is expected to provide technical, informational and career guidance to the employee in an effort to ensure appropriate employee development. The ODE PMO Office has served as an informal mentoring agent for minorities to facilitate their assimilation into the workforce.
In FY 2000, ODE continued and expanded the ODE Intern Program. The program allows 4-5 college students to work in a practical work environment, gain entry level professional "real work" experience and work alongside some the Agency’s top healthcare authorities. Special attention is given to minority candidates. ODE continues to expand the program to include American and foreign professionals.
ODE, along with a sister organization, the Office of Health Industry Programs, continued the DSMA/ODE Exchange Program, an internal program that allows scientific reviewers from each Office to exchange places for a period of 60-90 days. Each participant is expected to learn about the operations and integral workings of the other Office.
ODE established the ODE Employee Exchange Program. The primary purpose of the program is to allow staff members the opportunity to work in other Offices and Centers within FDA to keep abreast of current advances and practices in sister organizations, as well as changes in legislation, regulations, scientific and legislative literature in other medical fields.
In an effort to increase the hiring of minorities within the Center, ODE participated in various recruitment and job fairs including the President’s Committee on the Employment of People with Disabilities Job Fair and the Hispanic Association of Colleges and Universities (HACU) Employment Fair.
ODE tracking system changes included premarket database enhancements, revised query programs and performance reports, and the development and implementation of the CLIA categorization tracking system, the 510(k) Exempt CLIA submission tracking system, and the 513(g) (device determination) tracking system. In addition, revisions were made in the Classification database for the expanded third party review and to the PMA modular review tracking system. The ODE division tracking system was updated to accommodate CLIA and 513(g) submissions and to produce new reports. All tracking systems were modified to reflect the division reorganizations of ODE.
ODE continued to upgrade equipment in order to improve the processing of applications and interactions with the regulated industry and the public. Speakerphones, Windows NT on all PCs, laptops, PCs, laser printers, uninterruptible power supplies, and facsimile machines were among the improvements. In addition, ODE contributed funds to upgrade the Center’s telephone system to enable dial-in access speeds to approach 56K and to help with the development of a new storage system for archived documents.
In FY 00, ODE received 113 electronic submissions for PMAs, IDEs, and 510(k)s from 37 different sponsors. ODE reviewers received parts of submissions in electronic format such as additional information, summaries of safety and effectiveness, and proposed labeling and those submissions were recorded as electronic submissions. Prior contact with an ODE division is requested before developing and sending an electronic submission. Instructions for submitting electronic submissions can be found on the FDA home page.
The ODE use of videoconferencing to interact with the regulated industry continued to show limited use. In FY 00, 8 videoconferences were held involving industry, other Federal agencies and professional societies. 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.
ODE continues to provide information on the web that can be downloaded and searched through the CDRH home page. Information on Premarket Approval Applications (PMAs) and Premarket Notifications (510(k)s) can be found under the Popular Items/New Device Information on the CDRH home page.
Anyone can search the Releasable 510(k) and PMA databases, download 510(k) or PMA files, obtain the monthly PMA, HDE and 510(k) listings and Summaries of Safety and Effectiveness Data, and read about the "Real-Time" program for PMA supplements. In FY00, ODE posted 39 guidance documents on the web. In addition, information on ODE’s panel meeting schedules and summaries can be found on the internet at http://www.fda.gov/AdvisoryCommittees/default.htm.
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.
The Consumer Staff in FDA’s Center for Devices and Radiological Health, Division of Small Manufacturers Assistance 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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The FDA Breast Implant website for consumer information is available at http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/ BreastImplants/default.htm.
A new CDRH website entitled LASIK Eye Surgery: Learning About LASIK is available at http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/SurgeryandLifeSupport/ LASIK/default.htm.