FY 2001 ODE Annual Report - Part 5 - Program Support
In FY 01, ODE published 29 final guidance documents and published 11 draft guidance documents for comment. See INDUSTRY INFORMATION for a complete listing of all ODE guidance documents published in FY 01.
A central purpose of the Food and Drug Administration Modernization Act of 1997 (FDAMA) was to ensure the timely availability of safe and effective new products that would benefit the American public. While Congress wanted to reduce unnecessary burdens associated with the premarket clearance and approval processes, Congress did not intend to lower the statutory thresholds for substantial equivalence or reasonable assurance of safety and effectiveness. To help achieve this goal, Congress added sections 513(a)(3)(D)(ii) and 513(i)(1)(D) to the act.
These two sections of the law contain what are commonly referred to as the "least burdensome provisions" of the act. During the last couple years, CDRH has been working with the Least Burdensome Industry Task Force to develop an interpretation of the least burdensome provisions that would accurately capture Congress' intent and that could be implemented consistently by the agency and industry. Recently, a draft guidance was issued entitled, "The Least Burdensome Provisions of the FDA Modernization Act of 1997: Concept and Principles." As presented in this guidance, the agency considers the least burdensome concept to be one that could affect almost all premarket regulatory activities, including presubmission meetings with industry, premarket submissions, and the development of guidance documents and regulations.
The Level 1 draft was made available in the May 3, 2001 Federal Register, and the 90-day comment period for the draft ended on August 1, 2001. While almost all of the comments strongly supported the guidance and encouraged full implementation of it as soon as possible, several comments included recommendations for the agency. For example, it was recommended that FDA develop a training program for its staff on the least burdensome approach as well as ways to assess both the agency's success in implementing the principles and industry's satisfaction with FDa's incorporation of them into its daily activities. The agency agrees with many of these recommendations and has incorporated them into the guidance that is currently being finalized.
The agency has also developed several other guidances to contribute to the least burdensome effort. These include the guidance entitled, "Early Collaboration Meetings under the FDA Modernization Act (FDAMA)." A listing of all of the Center's least burdensome activities can be found on the Least Burdensome 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 Office of the Chief Mediator and Ombudsman. These formal submissions contain the material describing the requester's product and/or products and their proposal regarding which Center should be give lead designation over their product and whose authorities (Biological, Device or Drug) should apply.
In FY 01 CDRH participated in the review of 27 out of 30 (three were assigned wholly to CDER and CBER only) RFD's received by the FDA's Ombudsman's Office, in addition to completing the review of 7 RFDs received in FY 2000. The reviews of the 27 new requests were assigned to the ODE Divisions as follows; DDIGD was assigned 10 (ten) to review, DCRD was assigned to review 7 (seven), DGRND was assigned 5 (five), DRARD was assigned 4 (four) and DOED was assigned 1 (one). DCLD was not assigned any RFDs to review.
Out of the 27 FY 01 RFDs assigned to CDRH for review, 9 (nine) were not due for completion until FY 02. Of the RFD's whose reviews were completed, CDRH was assigned the lead center in 8 of those requests and 2 (two) were withdrawn before their review could be completed. Of the remaining RFDs the lead center designation was to either CDER (7) or CBER (1).
Congress passed the Clinical Laboratory Improvement Amendments in 1988, establishing quality standards for all laboratory testing to ensure the accuracy, reliability and timeliness of patient test results regardless of where the test was performed. The categorization of commercially marketed in vitro diagnostic tests under CLIA has been the responsibility of the FDA since February 2000. DCLD performs the CLIA complexity categorization that includes the assignment of these test systems to one of three CLIA regulatory categories (high, moderate and waived) based on their potential risk to public health. During FY01 DCLD performed categorizations on 132 High, 1962 Moderate, and 149 Waived tests. FDA, CDC, and CMS are working together to publish a final rule on CLIA standards. More information on the CLIA program can be found at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ IVDRegulatoryAssistance/ucm124105.htm.
The Office of Device Evaluation's Medical Devices Advisory Committee (MDAC) with its 18 panels provide clinical and scientific advice to FDA in several areas of activity fundamental to the regulation of medical devices. The most significant of these areas of activity are: (1) classification and reclassification of medical devices into one of three classes based on risk, (2) review and make recommendations on premarket submissions such as Premarket Approval Applications (PMAs), Product Development Protocols (PDPs), and Premarket Notification submissions (510ks), (3) provide advice on guidance documents which convey to industry and the agency staff FDA's expectations for studies and data for premarket review, and (4) provide input on issues or problems concerning the safety and effectiveness of medical devices.
In FY 01, ODE held 23 panel meetings. The panels reviewed and made recommendations on: 20 PMAs, 1 PMA supplement, 2 510(k)s, 2 reclassification petitions, and 8 general issues. The Dispute Resolution panel met twice: (1) to discuss a PMA and (2) to discuss a general issue. CDRH conducts training sessions for new panel members and consultants prior to their participation on a panel. In FY01, there were 19 training sessions for new members. The panels reviewed PMAs for significant medical device breakthrough technologies such as a collagen glaucoma drainage device, a embolic radiation therapy device, a percutaneous myocardial revascularization system, and an interactive wound and burn dressing.
A new draft guidance document, "Availability of Information Given to Advisory Committee Members in Connection with CDRH Open Public Meetings" issued for comment on July 18, 2001. This guidance document describes the process that CDRH intends to follow when making materials that are sent to advisory panel members publicly available.
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.
CDRH continuously recruits highly qualified experts to serve as members and consultants on our panels. Candidates are asked to provide detailed information concerning financial holdings, employment, and research grants and contracts to identify any potential conflicts of interest. Interested individuals should send their curriculum vitae to firstname.lastname@example.org.
The MDAC advisory panels are key to ensuring that the agency has access to the nation's most esteemed medical experts and to making the FDA medical device review process transparent to stakeholders. The Office of Device Evaluation greatly appreciates the significant contributions that the advisory panel members and consultants make to the medical device review program.
During this fiscal year, ODE considered about 51 cases concerning the integrity of data submitted to the agency in premarket applications. Under the Application Integrity Program (AIP), one firm was placed on the AIP list and AIP restrictions applied against this firm. AIP restrictions were removed from one firm during the fiscal year.
ODE handled 39 instances related to questions arising under the standards of conduct for employees. During FY 01, 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 868 FOI requests during FY 01, a decrease from 1,080 in the last fiscal year. During FY 01, the number of FOI requests closed was 1,048 compared to 1,146 in FY 00. The total number of FOI requests pending in ODE at the end of FY 01 is 420 compared to 621 in FY 00.
Congressional interest in ODE programs continued to be strong in FY 01. ODE staff responded to inquiries and participated in briefings on such topics as breast pumps, excimer lasers, Temporomandibular joint (TMJ), condom labeling, reuse, hip replacement, cosmetic facial stimulator, and 510(k) rescission proposed rule. ODE also participated in Congressional hearings held during FY 01 dealing with FDA's budget, FDAMA, and reuse of medical devices labeled for single use.
During FY 01, ODE staff authored 31 manuscripts for publication in professional and scientific journals and delivered 56 presentations at professional, scientific and trade association meetings. See Appendix B for a bibliography of publications.
In FY 01, ODE, in conjunction with the Orthopedic Surgical Manufacturers Association (OSMA), sponsored one Vendor Day - an informative exhibit and exchange seminar with eleven device manufacturers on Total Anthroplasty, Fracture, Spine, and Other Devices.
In FY 01, 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 various medical device manufacturing firms but also to hospitals for the observations of certain devices in use. As a result, eleven firms and/or hospitals were visited to learn about 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 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 01, ODE continued the ODE Intern Program that allows 4-5 college students and/or professionals to work in a regulatory agency. The students gain entry level professional "real work" experience; the professionals gain experience working in a government regulatory environment; and both groups work alongside some of the agency's top healthcare authorities. Special attention is given to minority candidates. There were six (6) participants in the FY 01 program.
ODE continues to expand 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. Three center employees participated in FY 01.
To enhance the center's effort to increase the hiring of minorities and those with a disability, ODE participated in the 2001 National Employment Fair for Persons with a Disability; OPM's 2001 Strategic Compensation Conference and the Department's Hispanic Employment Forum.
ODE tracking system changes included premarket database enhancements, revised report and query programs, and modifications to the division level tracking system. In addition, enhancements were made to the CLIA tracking system to collect applicant contact information, to identify the CLIA data that should be updated and to produce new reports. Programs were modified to produce files of Third Party Accredited Persons to be placed on the Web, capture an indication of a "remanufactured device" in the IDE data entry program and add an indication of third party review to several 510k reports. All of the database modifications and data synchronization required to support the reorganization of DCLD in ODE were implemented.
After extensive equipment improvements in Fiscal Year 2000, ODE continued to make equipment improvements in Fiscal Year 2001 but on a smaller scale. ODE prepared PCs for a future upgrade to Windows 2000 and Microsoft Office 2000 with memory enhancements and also developed a plan to replace older and slower PCs. ODE installed Acrobat 5.0 on all PCs to allow greater flexibility in working with submissions in the PDF format, and to ensure compatibility with newer versions of IMAGE (CDRH's document archival system). ODE tested a new dialin system for ODE users, resolved problems with the new system and developed dialin solutions for WindowsNT and Windows 2000 users.
In Fiscal Year 2001, ODE received 156 electronic submissions for PMAs, IDEs, HDEs Hand 510(k)s from 47 different sponsors. In some cases, 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. For Fiscal Year 2002, ODE will revise its definition of electronic submission to represent submissions where a copy of the entire submission arrives at ODE in electronic format. 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.
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 Fiscal Year 2001, 9 video conferences were held involving industry, other Federal agencies and for internal use.
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 Fiscal Year 2001, ODE posted 40 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 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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